Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The HR Manager is a key individual contributor responsible for employee relations activities and is a business partner for our front-line leaders in a fast-paced manufacturing environment. Working in partnership with the site HR lead, this role focuses on proactively developing innovative HR solutions to drive issue resolution and a culture that attracts and retains an engaged workforce. This individual will work closely with the HR team both locally and remotely to define and accomplish HR goals that support business success. Responsibilities Partner with management, providing HR guidance and support in the areas of performance management and employee relations (e.g., coaching, counseling, career development, disciplinary actions) with guidance from the site HR lead. Develop strong, effective, working relationships across groups to lead and support managers and employees in the areas of retention, morale, productivity, policy interpretation and implementation, conflict resolution, and cultural integration. Manage and resolve complex employee relations issues. Conduct effective, thorough, and objective investigations. Assist managers and employees in understanding and applying HR and other tools, resources, and processes in order to maximize employee performance, achieve organizational effectiveness, and improve employee engagement. Engage in talent acquisition by actively participating in workforce planning and job description development; participate in recruiting efforts by offering coaching, behavioral interviewing guidance, and recommendations to ensure the best candidate is hired and retained. Proactively identify opportunities for initiatives and programs to enhance employee engagement and partner with supervisors, managers, and teams to execute HR strategies and activities for the site; work closely with HR team members to execute strategies that are focused on talent management, organizational effectiveness, and employee engagement. Answer employee questions about our HR programs, policies, and other people-related items, researching issues and responding with accuracy and a focus on the customer. Conduct exit interviews and provide data driven recommendations on employee retention. Manage and report department metrics; conduct research and analyze trends and metrics in partnership with the HR team and business to develop solutions, programs, and site policies and procedures. Own and execute on project deliverables, meet milestones and drive projects to completion. Maintain in-depth knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance. Qualifications Bachelor's degree required; Master's in Labor Relations, Business, Industrial Relations or similar discipline a plus. Minimum of 6 years of related Human Resources experience required, preferably in pharma, biopharma, or biotechnology. Experience working in a manufacturing, operations, or supply chain environment a plus. Ability to build strong relationships with peers and cross functionally with business partners. Demonstrated ability to leverage partner HR functions to deploy resources and programs that positively impact the business. Ability to communicate effectively with leaders and collaborate with staff at all levels and in a variety of situations with professionalism. Strong analytical and problem-solving skills. Ability to learn fast, know the business, handle ambiguity, and change course quickly when needed. Well organized with a disciplined approach to evaluating priorities in a changing environment. Demonstrated in-depth knowledge of employment/labor regulations. Ability to model and demonstrate work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The HR Manager is a key individual contributor responsible for employee relations activities and is a business partner for our front-line leaders in a fast-paced manufacturing environment. Working in partnership with the site HR lead, this role focuses on proactively developing innovative HR solutions to drive issue resolution and a culture that attracts and retains an engaged workforce. This individual will work closely with the HR team both locally and remotely to define and accomplish HR goals that support business success. Responsibilities Partner with management, providing HR guidance and support in the areas of performance management and employee relations (e.g., coaching, counseling, career development, disciplinary actions) with guidance from the site HR lead. Develop strong, effective, working relationships across groups to lead and support managers and employees in the areas of retention, morale, productivity, policy interpretation and implementation, conflict resolution, and cultural integration. Manage and resolve complex employee relations issues. Conduct effective, thorough, and objective investigations. Assist managers and employees in understanding and applying HR and other tools, resources, and processes in order to maximize employee performance, achieve organizational effectiveness, and improve employee engagement. Engage in talent acquisition by actively participating in workforce planning and job description development; participate in recruiting efforts by offering coaching, behavioral interviewing guidance, and recommendations to ensure the best candidate is hired and retained. Proactively identify opportunities for initiatives and programs to enhance employee engagement and partner with supervisors, managers, and teams to execute HR strategies and activities for the site; work closely with HR team members to execute strategies that are focused on talent management, organizational effectiveness, and employee engagement. Answer employee questions about our HR programs, policies, and other people-related items, researching issues and responding with accuracy and a focus on the customer. Conduct exit interviews and provide data driven recommendations on employee retention. Manage and report department metrics; conduct research and analyze trends and metrics in partnership with the HR team and business to develop solutions, programs, and site policies and procedures. Own and execute on project deliverables, meet milestones and drive projects to completion. Maintain in-depth knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance. Qualifications Bachelor's degree required; Master's in Labor Relations, Business, Industrial Relations or similar discipline a plus. Minimum of 6 years of related Human Resources experience required, preferably in pharma, biopharma, or biotechnology. Experience working in a manufacturing, operations, or supply chain environment a plus. Ability to build strong relationships with peers and cross functionally with business partners. Demonstrated ability to leverage partner HR functions to deploy resources and programs that positively impact the business. Ability to communicate effectively with leaders and collaborate with staff at all levels and in a variety of situations with professionalism. Strong analytical and problem-solving skills. Ability to learn fast, know the business, handle ambiguity, and change course quickly when needed. Well organized with a disciplined approach to evaluating priorities in a changing environment. Demonstrated in-depth knowledge of employment/labor regulations. Ability to model and demonstrate work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The HR Manager is a key individual contributor responsible for employee relations activities and is a business partner for our front-line leaders in a fast-paced manufacturing environment. Working in partnership with the site HR lead, this role focuses on proactively developing innovative HR solutions to drive issue resolution and a culture that attracts and retains an engaged workforce. This individual will work closely with the HR team both locally and remotely to define and accomplish HR goals that support business success. Responsibilities Partner with management, providing HR guidance and support in the areas of performance management and employee relations (e.g., coaching, counseling, career development, disciplinary actions) with guidance from the site HR lead. Develop strong, effective, working relationships across groups to lead and support managers and employees in the areas of retention, morale, productivity, policy interpretation and implementation, conflict resolution, and cultural integration. Manage and resolve complex employee relations issues. Conduct effective, thorough, and objective investigations. Assist managers and employees in understanding and applying HR and other tools, resources, and processes in order to maximize employee performance, achieve organizational effectiveness, and improve employee engagement. Engage in talent acquisition by actively participating in workforce planning and job description development; participate in recruiting efforts by offering coaching, behavioral interviewing guidance, and recommendations to ensure the best candidate is hired and retained. Proactively identify opportunities for initiatives and programs to enhance employee engagement and partner with supervisors, managers, and teams to execute HR strategies and activities for the site; work closely with HR team members to execute strategies that are focused on talent management, organizational effectiveness, and employee engagement. Answer employee questions about our HR programs, policies, and other people-related items, researching issues and responding with accuracy and a focus on the customer. Conduct exit interviews and provide data driven recommendations on employee retention. Manage and report department metrics; conduct research and analyze trends and metrics in partnership with the HR team and business to develop solutions, programs, and site policies and procedures. Own and execute on project deliverables, meet milestones and drive projects to completion. Maintain in-depth knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance. Qualifications Bachelor's degree required; Master's in Labor Relations, Business, Industrial Relations or similar discipline a plus. Minimum of 6 years of related Human Resources experience required, preferably in pharma, biopharma, or biotechnology. Experience working in a manufacturing, operations, or supply chain environment a plus. Ability to build strong relationships with peers and cross functionally with business partners. Demonstrated ability to leverage partner HR functions to deploy resources and programs that positively impact the business. Ability to communicate effectively with leaders and collaborate with staff at all levels and in a variety of situations with professionalism. Strong analytical and problem-solving skills. Ability to learn fast, know the business, handle ambiguity, and change course quickly when needed. Well organized with a disciplined approach to evaluating priorities in a changing environment. Demonstrated in-depth knowledge of employment/labor regulations. Ability to model and demonstrate work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The HR Manager is a key individual contributor responsible for employee relations activities and is a business partner for our front-line leaders in a fast-paced manufacturing environment. Working in partnership with the site HR lead, this role focuses on proactively developing innovative HR solutions to drive issue resolution and a culture that attracts and retains an engaged workforce. This individual will work closely with the HR team both locally and remotely to define and accomplish HR goals that support business success. Responsibilities Partner with management, providing HR guidance and support in the areas of performance management and employee relations (e.g., coaching, counseling, career development, disciplinary actions) with guidance from the site HR lead. Develop strong, effective, working relationships across groups to lead and support managers and employees in the areas of retention, morale, productivity, policy interpretation and implementation, conflict resolution, and cultural integration. Manage and resolve complex employee relations issues. Conduct effective, thorough, and objective investigations. Assist managers and employees in understanding and applying HR and other tools, resources, and processes in order to maximize employee performance, achieve organizational effectiveness, and improve employee engagement. Engage in talent acquisition by actively participating in workforce planning and job description development; participate in recruiting efforts by offering coaching, behavioral interviewing guidance, and recommendations to ensure the best candidate is hired and retained. Proactively identify opportunities for initiatives and programs to enhance employee engagement and partner with supervisors, managers, and teams to execute HR strategies and activities for the site; work closely with HR team members to execute strategies that are focused on talent management, organizational effectiveness, and employee engagement. Answer employee questions about our HR programs, policies, and other people-related items, researching issues and responding with accuracy and a focus on the customer. Conduct exit interviews and provide data driven recommendations on employee retention. Manage and report department metrics; conduct research and analyze trends and metrics in partnership with the HR team and business to develop solutions, programs, and site policies and procedures. Own and execute on project deliverables, meet milestones and drive projects to completion. Maintain in-depth knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance. Qualifications Bachelor's degree required; Master's in Labor Relations, Business, Industrial Relations or similar discipline a plus. Minimum of 6 years of related Human Resources experience required, preferably in pharma, biopharma, or biotechnology. Experience working in a manufacturing, operations, or supply chain environment a plus. Ability to build strong relationships with peers and cross functionally with business partners. Demonstrated ability to leverage partner HR functions to deploy resources and programs that positively impact the business. Ability to communicate effectively with leaders and collaborate with staff at all levels and in a variety of situations with professionalism. Strong analytical and problem-solving skills. Ability to learn fast, know the business, handle ambiguity, and change course quickly when needed. Well organized with a disciplined approach to evaluating priorities in a changing environment. Demonstrated in-depth knowledge of employment/labor regulations. Ability to model and demonstrate work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
We Make Life More Rewarding and Dignified Location: Libertyville Department: Operations Summary: The Manager of Hollister Corporate Facilities will be responsible for effectively leading facilities maintenance staff and all resources involved in planning and maintaining the Hollister campus. Reporting to the Senior Manager of Global Facilities you will be identified as a key partner for the organization to identify, quantify, and justify key initiatives across the campus ensuring Corporate Facilities projects align with corporate objectives. The successful candidate will need to excel in leading teams, managing capital projects and be driven to providing the highest levels of service to a growing organization. Responsibilities: Work with Facilities Managers worldwide to develop sustainable, long term corporate facilities strategies Foster culture aligned with Hollister values Manages outside vendors, outside projects, negotiation of contracts, resourcing, and leadership of facilities engineering group Manage in house maintenance staff to include performance management, development and training Manage predictive, preventative, and corrective maintenance programs Supervise maintenance and repair of the facilities and equipment Function as lead engineer for all decisions related to facilities and plant equipment. Lead problem solving activities including root cause analysis Respond appropriately to emergencies or urgent issues as the arise identifying appropriate next steps and proper communications Provide prompt responses to request and issues to facilities occupants Directing, coordinating, and planning essential central services Manage contractor and vendor relations continually evaluating capabilities and competencies Project management, supervision, and coordination of contractor work Implement programs and provide appropriate leadership Using performance management techniques to monitor and demonstrate achievement of agreed service levels and to lead on improvement Collaborate with cross functional leaders to create long range planning for the facility and plant equipment Actively drive departmental financial planning cycles and manage cost to plan Develop, refine, and manage immediate and long range capital plan Input and monitor expenses and payments Conduct and document regular facilities inspections Manage and review service contracts to ensure facilities management needs are being met Negotiate contracts to optimize delivery and cost savings Proactively drive and support safety and safety initiatives Coordinate cross functionally to allocate office space according to company needs Business Acumen Understand accounting principles, capital and expense planning in support of project and departmental performance Contribute to creation of project based integrated business plans Utilize resource planning software to support department and corporate resource monitoring Communication Effectively communicate with cross-functional team members Frequently exposed to senior leadership to provide situational updates Socialize project status throughout operations and engineering functions Present updates at project milestone meetings Use clearly understood metrics to report progress to management Create written reports and best practice documents for use throughout function and organization Other Provide technical consultation and support to Global Engineering organization Prepare project scope definitions and cost estimates for key related projects Prepare reports or financial justifications for financial authorization and effectively communicate the results Requirements: Bachelors of Science in Engineering or related field is required Masters of Science in Engineering or MBA preferred 5 years minimum of supervisory/managerial experience 8 years of relevant industry experience Facilities Management experience Experience applying knowledge of Building Automation Systems, fire systems, and general construction Working knowledge of electrical and mechanical systems; plumbing, carpentry, painting, dry walling, electrical and HVAC maintenance and operations is required Knowledge of OSHA and environmental regulations and preventive maintenance systems Knowledge of building codes, trade standards, and general practices within the maintenance field Experience reading and understanding blueprints and schematics Excellent analytical and problem-solving skills Demonstrated initiative and self-motivation Must speak and write in English. Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 28173 Apply Now!
Mar 31, 2020
Full time
We Make Life More Rewarding and Dignified Location: Libertyville Department: Operations Summary: The Manager of Hollister Corporate Facilities will be responsible for effectively leading facilities maintenance staff and all resources involved in planning and maintaining the Hollister campus. Reporting to the Senior Manager of Global Facilities you will be identified as a key partner for the organization to identify, quantify, and justify key initiatives across the campus ensuring Corporate Facilities projects align with corporate objectives. The successful candidate will need to excel in leading teams, managing capital projects and be driven to providing the highest levels of service to a growing organization. Responsibilities: Work with Facilities Managers worldwide to develop sustainable, long term corporate facilities strategies Foster culture aligned with Hollister values Manages outside vendors, outside projects, negotiation of contracts, resourcing, and leadership of facilities engineering group Manage in house maintenance staff to include performance management, development and training Manage predictive, preventative, and corrective maintenance programs Supervise maintenance and repair of the facilities and equipment Function as lead engineer for all decisions related to facilities and plant equipment. Lead problem solving activities including root cause analysis Respond appropriately to emergencies or urgent issues as the arise identifying appropriate next steps and proper communications Provide prompt responses to request and issues to facilities occupants Directing, coordinating, and planning essential central services Manage contractor and vendor relations continually evaluating capabilities and competencies Project management, supervision, and coordination of contractor work Implement programs and provide appropriate leadership Using performance management techniques to monitor and demonstrate achievement of agreed service levels and to lead on improvement Collaborate with cross functional leaders to create long range planning for the facility and plant equipment Actively drive departmental financial planning cycles and manage cost to plan Develop, refine, and manage immediate and long range capital plan Input and monitor expenses and payments Conduct and document regular facilities inspections Manage and review service contracts to ensure facilities management needs are being met Negotiate contracts to optimize delivery and cost savings Proactively drive and support safety and safety initiatives Coordinate cross functionally to allocate office space according to company needs Business Acumen Understand accounting principles, capital and expense planning in support of project and departmental performance Contribute to creation of project based integrated business plans Utilize resource planning software to support department and corporate resource monitoring Communication Effectively communicate with cross-functional team members Frequently exposed to senior leadership to provide situational updates Socialize project status throughout operations and engineering functions Present updates at project milestone meetings Use clearly understood metrics to report progress to management Create written reports and best practice documents for use throughout function and organization Other Provide technical consultation and support to Global Engineering organization Prepare project scope definitions and cost estimates for key related projects Prepare reports or financial justifications for financial authorization and effectively communicate the results Requirements: Bachelors of Science in Engineering or related field is required Masters of Science in Engineering or MBA preferred 5 years minimum of supervisory/managerial experience 8 years of relevant industry experience Facilities Management experience Experience applying knowledge of Building Automation Systems, fire systems, and general construction Working knowledge of electrical and mechanical systems; plumbing, carpentry, painting, dry walling, electrical and HVAC maintenance and operations is required Knowledge of OSHA and environmental regulations and preventive maintenance systems Knowledge of building codes, trade standards, and general practices within the maintenance field Experience reading and understanding blueprints and schematics Excellent analytical and problem-solving skills Demonstrated initiative and self-motivation Must speak and write in English. Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 28173 Apply Now!
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Quality Control (QC) Group is part of the Quality organization and is responsible for testing of raw materials, in-process, release, and stability samples. The QC Supervisor will be primarily responsible for overseeing testing which is performed by the QC Analysts. In this role, they will supervise a team of QC Analysts. Additionally, the QC Supervisor will review data, perform administrational duties associated with a leadership role, and actively perform testing if needed. The successful candidate will work in a cGLP environment and must have working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded. Skills in statistics required to effectively analyze trends is also desired. Responsibilities Oversee the daily activities within the QC department in an efficient manner, assuring that the Avexis core values (Integrity, Tenacity, and Teamwork) are reinforced. Perform mid-year and end of year evaluations. Lead and coach a team of QC Analysts. Drive testing efficiencies in order to reduced testing time and costs, improve compliance, and reduce safety risks. Perform equipment repair. Assure training is up to date for the team. Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Support strategic proposals, progress updates and presentations to all levels of the site organization. Qualifications Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience. Prior leadership experience is desired but not required. Prior experience testing in a GLP environment is required. Investigational stills with respect to laboratory investigations required. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and have the ability to adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track. Must have strong communication skills both verbally and written. Must have proven logic and decision-making abilities, critical thinking skills. Must be able to accommodate testing schedule as required. The ability to effectively communicate at all levels of the organization is required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Quality Control (QC) Group is part of the Quality organization and is responsible for testing of raw materials, in-process, release, and stability samples. The QC Supervisor will be primarily responsible for overseeing testing which is performed by the QC Analysts. In this role, they will supervise a team of QC Analysts. Additionally, the QC Supervisor will review data, perform administrational duties associated with a leadership role, and actively perform testing if needed. The successful candidate will work in a cGLP environment and must have working knowledge of a QC environment, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented and compliant minded. Skills in statistics required to effectively analyze trends is also desired. Responsibilities Oversee the daily activities within the QC department in an efficient manner, assuring that the Avexis core values (Integrity, Tenacity, and Teamwork) are reinforced. Perform mid-year and end of year evaluations. Lead and coach a team of QC Analysts. Drive testing efficiencies in order to reduced testing time and costs, improve compliance, and reduce safety risks. Perform equipment repair. Assure training is up to date for the team. Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner. Support strategic proposals, progress updates and presentations to all levels of the site organization. Qualifications Bachelor of Arts/Science or equivalent combination of education with strong and broad relevant experience. Prior leadership experience is desired but not required. Prior experience testing in a GLP environment is required. Investigational stills with respect to laboratory investigations required. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and have the ability to adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track. Must have strong communication skills both verbally and written. Must have proven logic and decision-making abilities, critical thinking skills. Must be able to accommodate testing schedule as required. The ability to effectively communicate at all levels of the organization is required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 ( SOD1 ) gene. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The QC Analyst is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification/validations. A potential candidate should have experience performing analytical techniques such as PCR, immunoassays, chromatography, AUC, and electrophoresis. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site. Responsibilities Perform testing of in-process, release, or stability samples. Perform established analytical methods such as PCR, immunoassays, chromatography, AUC, and electrophoresis to support QC operations. Participate in assay troubleshooting, qualification and validation if needed. Manage the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems. Write and revise documents such as SOPs and technical reports. Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs. Perform other related duties as required. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 1 year GMP lab experience and at least 2 years of industry experience. Excellent oral and written communication skills with strong technical writing experience required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 ( SOD1 ) gene. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The QC Analyst is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification/validations. A potential candidate should have experience performing analytical techniques such as PCR, immunoassays, chromatography, AUC, and electrophoresis. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site. Responsibilities Perform testing of in-process, release, or stability samples. Perform established analytical methods such as PCR, immunoassays, chromatography, AUC, and electrophoresis to support QC operations. Participate in assay troubleshooting, qualification and validation if needed. Manage the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems. Write and revise documents such as SOPs and technical reports. Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs. Perform other related duties as required. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 1 year GMP lab experience and at least 2 years of industry experience. Excellent oral and written communication skills with strong technical writing experience required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The QC Analyst is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification/validations. A potential candidate should have experience performing analytical techniques such as PCR, immunoassays, chromatography, AUC, and electrophoresis. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site. Responsibilities Perform testing of in-process, release, or stability samples. Perform established analytical methods such as PCR, immunoassays, chromatography, AUC, and electrophoresis to support QC operations. Participate in assay troubleshooting, qualification and validation if needed. Manage the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems. Write and revise documents such as SOPs and technical reports. Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs. Perform other related duties as required. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 1 year GMP lab experience and at least 2 years of industry experience. Excellent oral and written communication skills with strong technical writing experience required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team. The QC Analyst is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification/validations. A potential candidate should have experience performing analytical techniques such as PCR, immunoassays, chromatography, AUC, and electrophoresis. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management and support of investigations. The QC Analyst may also support and identification and implementation of corrective and preventive actions. He/she should be able to work effectively within the group, within Quality, and across site. Responsibilities Perform testing of in-process, release, or stability samples. Perform established analytical methods such as PCR, immunoassays, chromatography, AUC, and electrophoresis to support QC operations. Participate in assay troubleshooting, qualification and validation if needed. Manage the procurement, use, and maintenance of scientific equipment, instrumentation, and computer systems. Write and revise documents such as SOPs and technical reports. Support investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Liaise with other departments including Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs. Perform other related duties as required. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 1 year GMP lab experience and at least 2 years of industry experience. Excellent oral and written communication skills with strong technical writing experience required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The QC Sample Coordinator provides sample control support in GMP and non-GMP Manufacturing facility. This includes the administration of QC in-process, release, and stability samples, associated document coordination, and collection of data. A potential candidate will possess an understanding of the requirements of Sample Coordination in a GMP laboratory. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The QC Sample Coordinator may also support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The QC Sample Coordinator should be able to work effectively within the group, within Quality, and across the site. Responsibilities Create sample tracking and inventory system to track development samples Generate sample submission forms for various testing facilities Collect sample forecasts to ensure lead time notice Confirm testing was complete when sample invoices arrive Follow/track international shipments, and alert logistics group of any customs clearance issues Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments Create equipment, inventory, and sample receipt and tracking logbooks Draft sample management procedures Communicate with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs. Write and revise documents such as SOPs and technical reports. Qualifications Minimum Associates Degree in scientific field, B.A. or B.S. in microbiology or related scientific field preferred Minimum of 2 years of related experience in a GMP Quality Control laboratory. Excellent oral and written communication skills with strong technical writing experience required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The QC Sample Coordinator provides sample control support in GMP and non-GMP Manufacturing facility. This includes the administration of QC in-process, release, and stability samples, associated document coordination, and collection of data. A potential candidate will possess an understanding of the requirements of Sample Coordination in a GMP laboratory. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The QC Sample Coordinator may also support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The QC Sample Coordinator should be able to work effectively within the group, within Quality, and across the site. Responsibilities Create sample tracking and inventory system to track development samples Generate sample submission forms for various testing facilities Collect sample forecasts to ensure lead time notice Confirm testing was complete when sample invoices arrive Follow/track international shipments, and alert logistics group of any customs clearance issues Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments Create equipment, inventory, and sample receipt and tracking logbooks Draft sample management procedures Communicate with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs. Write and revise documents such as SOPs and technical reports. Qualifications Minimum Associates Degree in scientific field, B.A. or B.S. in microbiology or related scientific field preferred Minimum of 2 years of related experience in a GMP Quality Control laboratory. Excellent oral and written communication skills with strong technical writing experience required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
We Make Life More Rewarding and Dignified Location: Libertyville Department: Finance Senior Financial Analyst - Corporate FP&A JOIN A TEAM THAT SHAPES THE FUTURE As a member of our Corporate Financial Planning & Analysis team, your work will be used to inform strategic decisions, deliver on our shared commitments, and identify potential areas for improvements in the evolving Medical Device industry. You will build your professional experience by partnering directly with senior leaders and executives to build annual operating plans and assess progress on key initiatives. You will provide financial support in several areas such as new product development, running scenarios on future strategies, and reporting/forecasting of Corporate Functions. By sharing your insights from financial reporting and analytics, you will shape the future of how we make a difference in the journey of life for our customers, colleagues, and communities. You will use your judgment to know when to focus on the detail ensuring accuracy and timeliness, and when to identify themes in the data while partnering with your colleagues around the world and in other functions to identify innovative ways to do things differently to achieve our goals. Your work will be focused on an assigned client group contributing to the success of the process from a global perspective. The expectation is that you will learn all of the various responsibilities within the FP&A team. This Corporate position will ensure that you develop skills that will support your career growth at Hollister. With a strong performance, the expectation is that movement to other positions within the Finance Department or elsewhere within the Company will occur in 2 years or less. RESPONSIBILITIES: Reporting & Analysis - 30% Planning & Forecasting - 30% Business Partnering - 25% Special Projects - 15% QUALIFICATIONS: Education BS Degree in Finance or Accounting MBA, Master's Degree or CPA is Highly prefered (Candidate should be completed, working towards or in process of applying to an advanced degree program) Professional Experience 6+ years in an analytical role involving demonstrated business partnership and leadership (e.g., leading a project) Required Specialized Skills/technical Knowledge Strong analytical skills Ability to understand business needs and support the organization with value added analysis Comfortable providing recommendations to Executive Management Ability to work across multiple layers of the organization Ability to effectively and autonomously prioritize multiple demands with support of management Exceptional follow-up skills and initiative Proficient in Microsoft Suite of products - in particular Excel Proficient in ERP software applications such as SAP, EDW, and BPC (preferred) Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for critical care, continence care, and wound care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 27592 Apply Now!
Mar 31, 2020
Full time
We Make Life More Rewarding and Dignified Location: Libertyville Department: Finance Senior Financial Analyst - Corporate FP&A JOIN A TEAM THAT SHAPES THE FUTURE As a member of our Corporate Financial Planning & Analysis team, your work will be used to inform strategic decisions, deliver on our shared commitments, and identify potential areas for improvements in the evolving Medical Device industry. You will build your professional experience by partnering directly with senior leaders and executives to build annual operating plans and assess progress on key initiatives. You will provide financial support in several areas such as new product development, running scenarios on future strategies, and reporting/forecasting of Corporate Functions. By sharing your insights from financial reporting and analytics, you will shape the future of how we make a difference in the journey of life for our customers, colleagues, and communities. You will use your judgment to know when to focus on the detail ensuring accuracy and timeliness, and when to identify themes in the data while partnering with your colleagues around the world and in other functions to identify innovative ways to do things differently to achieve our goals. Your work will be focused on an assigned client group contributing to the success of the process from a global perspective. The expectation is that you will learn all of the various responsibilities within the FP&A team. This Corporate position will ensure that you develop skills that will support your career growth at Hollister. With a strong performance, the expectation is that movement to other positions within the Finance Department or elsewhere within the Company will occur in 2 years or less. RESPONSIBILITIES: Reporting & Analysis - 30% Planning & Forecasting - 30% Business Partnering - 25% Special Projects - 15% QUALIFICATIONS: Education BS Degree in Finance or Accounting MBA, Master's Degree or CPA is Highly prefered (Candidate should be completed, working towards or in process of applying to an advanced degree program) Professional Experience 6+ years in an analytical role involving demonstrated business partnership and leadership (e.g., leading a project) Required Specialized Skills/technical Knowledge Strong analytical skills Ability to understand business needs and support the organization with value added analysis Comfortable providing recommendations to Executive Management Ability to work across multiple layers of the organization Ability to effectively and autonomously prioritize multiple demands with support of management Exceptional follow-up skills and initiative Proficient in Microsoft Suite of products - in particular Excel Proficient in ERP software applications such as SAP, EDW, and BPC (preferred) Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for critical care, continence care, and wound care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 27592 Apply Now!
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Planning Manager, Global Supply Chain is responsible to maintain global capacity planning as well as producing attainable production plans for the AveXis network. Responsibilities Perform assessments of inventory levels of multi-region products, while relaying supply risks and mitigation plans. Partners, cross-functionally, with site supply chain heads, clinical operations, commercial operations, and finance to ensure strategic alignment between supply capabilities and forecasted demand. Ensure workplace safety and compliance while maintaining the effectiveness of the AveXis Quality System. Maintain global production planning and capacity allocation process in support of S&OP initiatives. Translate global demand forecast into achievable production plans over the planning horizon. Allocate production requirements across AveXis manufacturing facilities while minimizing potential supply risk to the organization. Generate ad-hoc Supply Plan scenarios, as necessary Lead and facilitate multiple cross functional discussions to ensure supply risks are comprehended and supply needs are met. Tracks key metrics related to the commercial and clinical inventory and formulates improvement strategies, as needed. Effectively communicate supply risks and resulting mitigation strategies to senior leadership. Interpret and evaluate data to effectively make informed decisions. Translates corporate goals into functional areas goals while establishing processes and systems to achieve them. Other related duties as assigned. Qualifications Bachelor's Degree in Supply Chain, Engineering, Business Administration or a related field. 5 years' supply chain experience in pharmaceutical or other regulated and GxP environment(s). Strong knowledge of supply chain management. Knowledge of inventory management. ERP software experience. Demonstrated ability to operate in a fast-paced and rapidly changing environment. Collaborative working style. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Planning Manager, Global Supply Chain is responsible to maintain global capacity planning as well as producing attainable production plans for the AveXis network. Responsibilities Perform assessments of inventory levels of multi-region products, while relaying supply risks and mitigation plans. Partners, cross-functionally, with site supply chain heads, clinical operations, commercial operations, and finance to ensure strategic alignment between supply capabilities and forecasted demand. Ensure workplace safety and compliance while maintaining the effectiveness of the AveXis Quality System. Maintain global production planning and capacity allocation process in support of S&OP initiatives. Translate global demand forecast into achievable production plans over the planning horizon. Allocate production requirements across AveXis manufacturing facilities while minimizing potential supply risk to the organization. Generate ad-hoc Supply Plan scenarios, as necessary Lead and facilitate multiple cross functional discussions to ensure supply risks are comprehended and supply needs are met. Tracks key metrics related to the commercial and clinical inventory and formulates improvement strategies, as needed. Effectively communicate supply risks and resulting mitigation strategies to senior leadership. Interpret and evaluate data to effectively make informed decisions. Translates corporate goals into functional areas goals while establishing processes and systems to achieve them. Other related duties as assigned. Qualifications Bachelor's Degree in Supply Chain, Engineering, Business Administration or a related field. 5 years' supply chain experience in pharmaceutical or other regulated and GxP environment(s). Strong knowledge of supply chain management. Knowledge of inventory management. ERP software experience. Demonstrated ability to operate in a fast-paced and rapidly changing environment. Collaborative working style. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Strategic Buyer is responsible for working closing with Supply Chain, Manufacturing, MS&T, Quality and other site level groups to lead updates for both site and global tech ops leadership on material risks. Responsibilities Lead weekly critical raw material meetings and subsequently update site and global Tech Ops leadership on potential material supply constraints or shortages. Work with suppliers to allocate raw materials, manage deliveries, and expedite orders across our manufacturing network. Work with suppliers to mitigate supply risk and ensure no material shortages. Serve as a Subject Matter Expert on critical direct materials. Create detailed analysis and forecasts on direct materials in support of Global and Site Production Planning. Manage and lead change controls on raw materials when needed. Support Global Engineering by purchasing specified equipment and/or services for projects. Manage communications between site level and global purchasing. Monitor capability of suppliers to satisfy expectations of on-time delivery, quality, service, and price commitments (Included to but not limited to the understanding of impact to total cost). Work within documented procurement/planning system that complies with cGMP and FDA guidelines. Help identify and implement process improvements to the existing purchasing processes. Work with Finance on material forecasts, spend and savings reporting, and resolving accounts payable issues at a global level. Other related duties as assigned. Qualifications Bachelor's Degree in Business, Science, Supply Chain or a related field and 5 years professional purchasing experience in pharmaceutical or other regulated and GxP environment(s). Experience in purchasing and sourcing direct raw materials. Ability to solve problems involving several variables in fluid situations. Good communication and negotiation skills. Strong analytical skills. Must have the ability to work in or lead cross-functional teams. Strong Knowledge of ERP Systems and Microsoft Excel. Requires strong attention to detail and the ability to complete tasks independently. Able to thrive in a fast-paced, rapidly evolving environment. Travel - approximately 10% domestic and international. Preferred: Lean Six Sigma, ISO 9001:2005 experience. Knowledge of GMP pharmaceutical manufacturing. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Strategic Buyer is responsible for working closing with Supply Chain, Manufacturing, MS&T, Quality and other site level groups to lead updates for both site and global tech ops leadership on material risks. Responsibilities Lead weekly critical raw material meetings and subsequently update site and global Tech Ops leadership on potential material supply constraints or shortages. Work with suppliers to allocate raw materials, manage deliveries, and expedite orders across our manufacturing network. Work with suppliers to mitigate supply risk and ensure no material shortages. Serve as a Subject Matter Expert on critical direct materials. Create detailed analysis and forecasts on direct materials in support of Global and Site Production Planning. Manage and lead change controls on raw materials when needed. Support Global Engineering by purchasing specified equipment and/or services for projects. Manage communications between site level and global purchasing. Monitor capability of suppliers to satisfy expectations of on-time delivery, quality, service, and price commitments (Included to but not limited to the understanding of impact to total cost). Work within documented procurement/planning system that complies with cGMP and FDA guidelines. Help identify and implement process improvements to the existing purchasing processes. Work with Finance on material forecasts, spend and savings reporting, and resolving accounts payable issues at a global level. Other related duties as assigned. Qualifications Bachelor's Degree in Business, Science, Supply Chain or a related field and 5 years professional purchasing experience in pharmaceutical or other regulated and GxP environment(s). Experience in purchasing and sourcing direct raw materials. Ability to solve problems involving several variables in fluid situations. Good communication and negotiation skills. Strong analytical skills. Must have the ability to work in or lead cross-functional teams. Strong Knowledge of ERP Systems and Microsoft Excel. Requires strong attention to detail and the ability to complete tasks independently. Able to thrive in a fast-paced, rapidly evolving environment. Travel - approximately 10% domestic and international. Preferred: Lean Six Sigma, ISO 9001:2005 experience. Knowledge of GMP pharmaceutical manufacturing. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
What you'll do: Support essential project duties including:Help design and create content for marketing materials that fall in line with our company's branding and messaging. Ex: collateral, mailers, ads, project inserts, digital graphics, etc.Prep folders, presentations, event items upon request.Assist in marketing and advertising promotional activities (e.g. social media, direct mail, and web) Monitor all social media platforms for trending news, ideas, and feedback.Assist in market research assignments.Help with the collecting, organizing, and coordinating of various photography and video department initiatives. Experience with video editing is a plus. During the summer you will have the opportunity to go out on at least one job site visit.Assist in reviewing department's work for grammatical accuracy and overall design feedback. Who you are: We are pursuing candidates with the following qualifications: Enrolled in a 4 year college or university.Solution oriented, problem solver with a hands on and team oriented attitude.Ability to relate to a diverse group of individuals throughout the organization.Cumulative GPA of 3.0 or above preferred.Experience working in Adobe Creative Suite (InDesign, Illustrator, Photoshop, and Premier Pro) and Office Suite (Word, Excel, and PPT).Familiarity with social media strategies and platforms.Ability to take direction and absorb information quickly.Excellent verbal and written communication skills.Outstanding multitasking abilities.Comfortability with using a PC. * Please share any available design and writing samples for review. Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law. Graphic Design & Digital Marketing Intern With nearly $500 million in annual revenue and over 65 years of experience completing complex infrastructure projects, Aldridge is widely recognized as one of the leading contractors in the country. Aldridge has built a reputation for completing challenging projects in the transportation, power, utility and industrial markets while upholding our commitment to being Incident and Injury Free. Our strength comes from our team, with over 900 of the industry's best individuals driving the success of our organization. Aldridge provides quality work through innovation; finding better and more efficient ways to approach our projects and ensure customer satisfaction. We are searching for experienced Interns across the country. What you'll do: Support essential project duties including: Help design and create content for marketing materials that fall in line with our company's branding and messaging. Ex: collateral, mailers, ads, project inserts, digital graphics, etc. Prep folders, presentations, event items upon request. Assist in marketing and advertising promotional activities (e.g. social media, direct mail, and web) Monitor all social media platforms for trending news, ideas, and feedback. Assist in market research assignments. Help with the collecting, organizing, and coordinating of various photography and video department initiatives. Experience with video editing is a plus. During the summer you will have the opportunity to go out on at least one job site visit. Assist in reviewing department's work for grammatical accuracy and overall design feedback. Who you are: We are pursuing candidates with the following qualifications: Enrolled in a 4 year college or university. Solution oriented, problem solver with a hands on and team oriented attitude. Ability to relate to a diverse group of individuals throughout the organization. Cumulative GPA of 3.0 or above preferred. Experience working in Adobe Creative Suite (InDesign, Illustrator, Photoshop, and Premier Pro) and Office Suite (Word, Excel, and PPT). Familiarity with social media strategies and platforms. Ability to take direction and absorb information quickly. Excellent verbal and written communication skills. Outstanding multitasking abilities. Comfortability with using a PC. * Please share any available design and writing samples for review. Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law. This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status or marital status or any other characteristic protected by law. Aldridge Electric shall abide by the requirements of 41 CFR 60-741.5(a). This regulation prohibits discrimination against qualified individuals on the basis of disability, and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified individuals with disabilities. Aldridge Electric shall abide by the requirements of 41 CFR 60300.5(a). This regulation prohibits discrimination against qualified protected veterans and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans.
Mar 31, 2020
Full time
What you'll do: Support essential project duties including:Help design and create content for marketing materials that fall in line with our company's branding and messaging. Ex: collateral, mailers, ads, project inserts, digital graphics, etc.Prep folders, presentations, event items upon request.Assist in marketing and advertising promotional activities (e.g. social media, direct mail, and web) Monitor all social media platforms for trending news, ideas, and feedback.Assist in market research assignments.Help with the collecting, organizing, and coordinating of various photography and video department initiatives. Experience with video editing is a plus. During the summer you will have the opportunity to go out on at least one job site visit.Assist in reviewing department's work for grammatical accuracy and overall design feedback. Who you are: We are pursuing candidates with the following qualifications: Enrolled in a 4 year college or university.Solution oriented, problem solver with a hands on and team oriented attitude.Ability to relate to a diverse group of individuals throughout the organization.Cumulative GPA of 3.0 or above preferred.Experience working in Adobe Creative Suite (InDesign, Illustrator, Photoshop, and Premier Pro) and Office Suite (Word, Excel, and PPT).Familiarity with social media strategies and platforms.Ability to take direction and absorb information quickly.Excellent verbal and written communication skills.Outstanding multitasking abilities.Comfortability with using a PC. * Please share any available design and writing samples for review. Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law. Graphic Design & Digital Marketing Intern With nearly $500 million in annual revenue and over 65 years of experience completing complex infrastructure projects, Aldridge is widely recognized as one of the leading contractors in the country. Aldridge has built a reputation for completing challenging projects in the transportation, power, utility and industrial markets while upholding our commitment to being Incident and Injury Free. Our strength comes from our team, with over 900 of the industry's best individuals driving the success of our organization. Aldridge provides quality work through innovation; finding better and more efficient ways to approach our projects and ensure customer satisfaction. We are searching for experienced Interns across the country. What you'll do: Support essential project duties including: Help design and create content for marketing materials that fall in line with our company's branding and messaging. Ex: collateral, mailers, ads, project inserts, digital graphics, etc. Prep folders, presentations, event items upon request. Assist in marketing and advertising promotional activities (e.g. social media, direct mail, and web) Monitor all social media platforms for trending news, ideas, and feedback. Assist in market research assignments. Help with the collecting, organizing, and coordinating of various photography and video department initiatives. Experience with video editing is a plus. During the summer you will have the opportunity to go out on at least one job site visit. Assist in reviewing department's work for grammatical accuracy and overall design feedback. Who you are: We are pursuing candidates with the following qualifications: Enrolled in a 4 year college or university. Solution oriented, problem solver with a hands on and team oriented attitude. Ability to relate to a diverse group of individuals throughout the organization. Cumulative GPA of 3.0 or above preferred. Experience working in Adobe Creative Suite (InDesign, Illustrator, Photoshop, and Premier Pro) and Office Suite (Word, Excel, and PPT). Familiarity with social media strategies and platforms. Ability to take direction and absorb information quickly. Excellent verbal and written communication skills. Outstanding multitasking abilities. Comfortability with using a PC. * Please share any available design and writing samples for review. Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law. This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status or marital status or any other characteristic protected by law. Aldridge Electric shall abide by the requirements of 41 CFR 60-741.5(a). This regulation prohibits discrimination against qualified individuals on the basis of disability, and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified individuals with disabilities. Aldridge Electric shall abide by the requirements of 41 CFR 60300.5(a). This regulation prohibits discrimination against qualified protected veterans and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking an experienced Materials Quality Assurance professional to join us and contribute to our SQM operations as we continue to develop and maintain supplier quality standards to ensure AveXis products are manufactured to relevant patient safety and product quality standards in line with business requirements. This role is responsible, along with the Head of Supplier Quality, for ensuring that all manufacturing materials are in accordance with the Company's quality assurance program and quality/reliability standards to satisfy cGMP regulatory requirements and expectations. This role will provide critical expertise to the harmonization and maintenance of global material Specifications and Materials Review Board (MRB) in support of compliance oversight of existing raw materials and introduction of new raw materials. This role is based out of our current GMP manufacturing facilities either in Libertyville IL, Durham NC or Longmont CO. Responsibilities To support the Supplier Quality and External Manufacturing department with special focuses on establishing best practices and executing key strategies as follows: Develop and/or review and/or approve standards, policies, and procedures for all functions and departments involved with or related to the procurement, qualification, specification establishment and testing of all raw materials, as assigned Establish the Materials Review Board (MRB) process serving all AveXis manufacturing sites as well as R&D sites as appropriate Establish and execute the period maintenance program for all raw materials specifications Act as global SME and QA oversight for supporting raw material related quality events such as change controls, investigations and SCARs Act as the focal point for directing, escalating and approving key raw materials specifications from the QA standpoint Act as the departmental Liaison for supporting Regulatory CMC filing activities with regards to Materials controls and management Act as global SME in ensuring AveXis' materials management policy is aligned with Novartis' global standards and best practices Provide support during Health Authority inspections and internal audits representing materials management. Assist in performing inspection readiness activities and supplier audits. Provide key support on compliance audit and supplier monitoring for AveXis' material suppliers, including participation in business review meetings. Support the Sr. Director of the department on other duties assigned, such as Ownership of Health Authority responses and CAPA's as pertains to Supplier and Materials management. Qualifications 10-12 years of overall working experience in Biotech/Pharmaceutical industry, with at least 5 years of directly supporting External Suppliers Quality Assurance functions is required Previous working experience as a Materials Manager for minimum of 3 year(s) is required Strong Knowledge of GMP (US, EU and APAC), GCP/GLP, as well as ISO standards with regards to material and service providers is required Understanding of common biologics and sterile chemical/plastic materials manufacturing processes is strongly preferred In depth knowledge of supply chain and inventory management systems is strongly preferred Demonstrated experience in designing innovative and complex processes and delivering complex solutions that drive efficiency, compliance and improved values to organization Ability to present data effectively to senior management and external partners Strong attention to detail/quality focus; Balanced cost/quality/customer focus; Willingness and ability to collaborate with and influence other groups in a positive, team-based environment; Ability to gain consensus on key quality/operational decisions; Must also be able to hold others to account as required Must work with a sense of urgency and have the ability to be impartial and objective Must be an active learner and developer of self and others with excellent organizational skills BS or MS in Chemistry, Biochemistry, Molecular Biology or similar relevant field Certification in 6 Sigma, Lean Manufacturing, Kaizen, PMP, CQA or ASQ is highly desired Ability to Travel (10%) The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking an experienced Materials Quality Assurance professional to join us and contribute to our SQM operations as we continue to develop and maintain supplier quality standards to ensure AveXis products are manufactured to relevant patient safety and product quality standards in line with business requirements. This role is responsible, along with the Head of Supplier Quality, for ensuring that all manufacturing materials are in accordance with the Company's quality assurance program and quality/reliability standards to satisfy cGMP regulatory requirements and expectations. This role will provide critical expertise to the harmonization and maintenance of global material Specifications and Materials Review Board (MRB) in support of compliance oversight of existing raw materials and introduction of new raw materials. This role is based out of our current GMP manufacturing facilities either in Libertyville IL, Durham NC or Longmont CO. Responsibilities To support the Supplier Quality and External Manufacturing department with special focuses on establishing best practices and executing key strategies as follows: Develop and/or review and/or approve standards, policies, and procedures for all functions and departments involved with or related to the procurement, qualification, specification establishment and testing of all raw materials, as assigned Establish the Materials Review Board (MRB) process serving all AveXis manufacturing sites as well as R&D sites as appropriate Establish and execute the period maintenance program for all raw materials specifications Act as global SME and QA oversight for supporting raw material related quality events such as change controls, investigations and SCARs Act as the focal point for directing, escalating and approving key raw materials specifications from the QA standpoint Act as the departmental Liaison for supporting Regulatory CMC filing activities with regards to Materials controls and management Act as global SME in ensuring AveXis' materials management policy is aligned with Novartis' global standards and best practices Provide support during Health Authority inspections and internal audits representing materials management. Assist in performing inspection readiness activities and supplier audits. Provide key support on compliance audit and supplier monitoring for AveXis' material suppliers, including participation in business review meetings. Support the Sr. Director of the department on other duties assigned, such as Ownership of Health Authority responses and CAPA's as pertains to Supplier and Materials management. Qualifications 10-12 years of overall working experience in Biotech/Pharmaceutical industry, with at least 5 years of directly supporting External Suppliers Quality Assurance functions is required Previous working experience as a Materials Manager for minimum of 3 year(s) is required Strong Knowledge of GMP (US, EU and APAC), GCP/GLP, as well as ISO standards with regards to material and service providers is required Understanding of common biologics and sterile chemical/plastic materials manufacturing processes is strongly preferred In depth knowledge of supply chain and inventory management systems is strongly preferred Demonstrated experience in designing innovative and complex processes and delivering complex solutions that drive efficiency, compliance and improved values to organization Ability to present data effectively to senior management and external partners Strong attention to detail/quality focus; Balanced cost/quality/customer focus; Willingness and ability to collaborate with and influence other groups in a positive, team-based environment; Ability to gain consensus on key quality/operational decisions; Must also be able to hold others to account as required Must work with a sense of urgency and have the ability to be impartial and objective Must be an active learner and developer of self and others with excellent organizational skills BS or MS in Chemistry, Biochemistry, Molecular Biology or similar relevant field Certification in 6 Sigma, Lean Manufacturing, Kaizen, PMP, CQA or ASQ is highly desired Ability to Travel (10%) The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Warehouse Associate is responsible for receiving, sampling, storing, issuing and shipping materials. This individual will work with the supply chain team to ensure inventory levels are accurate and materials are stored in the appropriate locations. This individual will support all manufacturing activities at the site. Responsibilities Receive all materials that come into the facility. Locate and store all inventory items in the ERP system and physically locate them. Work with Production and Labs for materials that are required and need to be issued out. Responsible for shipping all materials out of the facility. This includes hazmat shipments, export shipments and temperature sensitive shipments. Responsible to stay current on all training and shipping regulations. Complete inventory cycle counts to maintain current inventory accuracy. Qualifications H.S. Diploma required, B.S. degree is preferred. This is an entry level position, but 1+ years of pharmaceutical warehouse material handling experience is preferred. Forklift certification preferred. Strong communication and organizational skills, detail oriented. Must be physically able to lift and move materials (up to 50 lbs.) safely. Must work well in a team setting. Must maintain a professional work environment. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Warehouse Associate is responsible for receiving, sampling, storing, issuing and shipping materials. This individual will work with the supply chain team to ensure inventory levels are accurate and materials are stored in the appropriate locations. This individual will support all manufacturing activities at the site. Responsibilities Receive all materials that come into the facility. Locate and store all inventory items in the ERP system and physically locate them. Work with Production and Labs for materials that are required and need to be issued out. Responsible for shipping all materials out of the facility. This includes hazmat shipments, export shipments and temperature sensitive shipments. Responsible to stay current on all training and shipping regulations. Complete inventory cycle counts to maintain current inventory accuracy. Qualifications H.S. Diploma required, B.S. degree is preferred. This is an entry level position, but 1+ years of pharmaceutical warehouse material handling experience is preferred. Forklift certification preferred. Strong communication and organizational skills, detail oriented. Must be physically able to lift and move materials (up to 50 lbs.) safely. Must work well in a team setting. Must maintain a professional work environment. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
What we are looking for: Aldridge is seeking a Heavy Equipment Mechanic to join our dynamic and energetic team. This role will be responsible for maintaining and repairing heavy equipment for our fleet department nationwide. What you'll do: Duties including: Repairing and maintaining heavy equipment including trucks, large foundation drilling rigs, and other support equipment Assuring that heavy equipment is in working order Responding to and communicating with internal customer requests for service Managing and mentoring mechanics as needed Who you are: We are pursuing candidates with the following qualifications: CDL license Class "A" 5+ years of experience Natural engineering and problem solving senses Welding and fabricating skills Basic computer skills Dependable and reliable attendance Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. What we offer: At Aldridge, you will be a valued member of our workforce and receive: 401K plan with matching contributions Competitive Salaries Health, Vision, and Dental Insurance Paid Time Off Health Savings Account, Health Reimbursement Account and Flexible Spending Accounts Health Wellness Programs Life and Disability Insurance Aldridge cares about our team members and the communities in which they live. We are proud to support and participate in: JDRF Bridges to Prosperity Bucks for Burn Special Olympics' Polar Plunge Feed My Starving Children Greenhouse Scholars This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law. Heavy Equipment Mechanic What we are looking for: Aldridge is seeking a Heavy Equipment Mechanic to join our dynamic and energetic team. This role will be responsible for maintaining and repairing heavy equipment for our fleet department nationwide. What you'll do: Duties including: Repairing and maintaining heavy equipment including trucks, large foundation drilling rigs, and other support equipment Assuring that heavy equipment is in working order Responding to and communicating with internal customer requests for service Managing and mentoring mechanics as needed Who you are: We are pursuing candidates with the following qualifications: CDL license Class "A" 5+ years of experience Natural engineering and problem solving senses Welding and fabricating skills Basic computer skills Dependable and reliable attendance Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. What we offer: At Aldridge, you will be a valued member of our workforce and receive: 401K plan with matching contributions Competitive Salaries Health, Vision, and Dental Insurance Paid Time Off Health Savings Account, Health Reimbursement Account and Flexible Spending Accounts Health Wellness Programs Life and Disability Insurance Aldridge cares about our team members and the communities in which they live. We are proud to support and participate in: JDRF Bridges to Prosperity Bucks for Burn Special Olympics' Polar Plunge Feed My Starving Children Greenhouse Scholars This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law.
Mar 31, 2020
Full time
What we are looking for: Aldridge is seeking a Heavy Equipment Mechanic to join our dynamic and energetic team. This role will be responsible for maintaining and repairing heavy equipment for our fleet department nationwide. What you'll do: Duties including: Repairing and maintaining heavy equipment including trucks, large foundation drilling rigs, and other support equipment Assuring that heavy equipment is in working order Responding to and communicating with internal customer requests for service Managing and mentoring mechanics as needed Who you are: We are pursuing candidates with the following qualifications: CDL license Class "A" 5+ years of experience Natural engineering and problem solving senses Welding and fabricating skills Basic computer skills Dependable and reliable attendance Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. What we offer: At Aldridge, you will be a valued member of our workforce and receive: 401K plan with matching contributions Competitive Salaries Health, Vision, and Dental Insurance Paid Time Off Health Savings Account, Health Reimbursement Account and Flexible Spending Accounts Health Wellness Programs Life and Disability Insurance Aldridge cares about our team members and the communities in which they live. We are proud to support and participate in: JDRF Bridges to Prosperity Bucks for Burn Special Olympics' Polar Plunge Feed My Starving Children Greenhouse Scholars This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law. Heavy Equipment Mechanic What we are looking for: Aldridge is seeking a Heavy Equipment Mechanic to join our dynamic and energetic team. This role will be responsible for maintaining and repairing heavy equipment for our fleet department nationwide. What you'll do: Duties including: Repairing and maintaining heavy equipment including trucks, large foundation drilling rigs, and other support equipment Assuring that heavy equipment is in working order Responding to and communicating with internal customer requests for service Managing and mentoring mechanics as needed Who you are: We are pursuing candidates with the following qualifications: CDL license Class "A" 5+ years of experience Natural engineering and problem solving senses Welding and fabricating skills Basic computer skills Dependable and reliable attendance Who we are: Aldridge, a family owned company, is one of the largest specialty contractors in the US, dealing in the power and transportation markets. We have built a reputation as a trusted source in the construction industry, with close to 70 years in business, 1,200 employees, and offices and job sites nationwide. Our continued success is attributed to our commitment to quality, attention to project planning, and dedication to an Incident and Injury Free (IIF) culture. Aldridge's mission is to build and strengthen America's infrastructure, and that starts with building the strongest team. We have sustained significant growth and foresee that continuing for years to come. Our ability to execute difficult projects is made possible by engaging passionate, forward thinking, and innovative people. What we offer: At Aldridge, you will be a valued member of our workforce and receive: 401K plan with matching contributions Competitive Salaries Health, Vision, and Dental Insurance Paid Time Off Health Savings Account, Health Reimbursement Account and Flexible Spending Accounts Health Wellness Programs Life and Disability Insurance Aldridge cares about our team members and the communities in which they live. We are proud to support and participate in: JDRF Bridges to Prosperity Bucks for Burn Special Olympics' Polar Plunge Feed My Starving Children Greenhouse Scholars This job-specific task list covers only the most important job duties. Employees assigned to this position title will also perform other occasional work assignments not mentioned above, including temporary assignments, training assignments, and other related duties. Aldridge is an EEO Employer and will recruit, hire, train, and promote persons in all job classifications without regard to race, color, national origin, age, religion, disability status, gender, sexual orientation, gender identity, genetic information, veteran status, marital status, or any other characteristic protected by law.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Director, Quality Systems is responsible for designing and implementing robust Quality Systems for our gene therapy manufacturing site in Libertyville, IL. This person will be responsible for the strategic site quality system design and work in collaboration with Manufacturing Operations to authorize written procedures including but not limited to monitor and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice. This position will develop quality related business systems such as deviation, CAPA, OOS, product complaints and facility wide GMP training and provide critical quality expertise to produce commercially approved Gene Therapy products. Responsibilities Develop and deliver a robust overall quality system, strategy, and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes. Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Hire and develop a high-performing quality team to ensure robust quality systems are implemented and sustained including: SOP/Document Management: Manage approval of all instruction sets, specifications, sampling instructions, test methods and other Quality control procedures directly related to operations and other cGMP activities. Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations. Lead site inspection preparation, management and response process. Provide quality input across the AveXis manufacturing network. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product. Experience with viral gene therapies and/or orphan disease indications is a plus. 10+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). Excellent oral and written communication skills with strong technical writing experience. Experience leading both internal and external vendor audits, identifying findings, driving resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. Approximately 10% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Mar 30, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Director, Quality Systems is responsible for designing and implementing robust Quality Systems for our gene therapy manufacturing site in Libertyville, IL. This person will be responsible for the strategic site quality system design and work in collaboration with Manufacturing Operations to authorize written procedures including but not limited to monitor and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice. This position will develop quality related business systems such as deviation, CAPA, OOS, product complaints and facility wide GMP training and provide critical quality expertise to produce commercially approved Gene Therapy products. Responsibilities Develop and deliver a robust overall quality system, strategy, and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes. Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Hire and develop a high-performing quality team to ensure robust quality systems are implemented and sustained including: SOP/Document Management: Manage approval of all instruction sets, specifications, sampling instructions, test methods and other Quality control procedures directly related to operations and other cGMP activities. Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations. Lead site inspection preparation, management and response process. Provide quality input across the AveXis manufacturing network. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product. Experience with viral gene therapies and/or orphan disease indications is a plus. 10+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). Excellent oral and written communication skills with strong technical writing experience. Experience leading both internal and external vendor audits, identifying findings, driving resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. Approximately 10% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
We Make Life More Rewarding and Dignified Location: Libertyville Department: Information Technology Summary: The role of the Specialist SharePoint Super User is to provide customer support, customizing and troubleshooting of existing SharePoint pages. This will include out-of-the-box workflow automation to support the business as well as creating and maintaining customer documentation and training. The Specialist SharePoint Support will work with internal Information Technology teams to resolve issues and questions with current web-based applications and services. This also includes supporting and maintaining third-party add-ons to the SharePoint environment. The Specialist SharePoint Support will address a multitude of requests and issues from customers in regards to their team and project sites and will be able to address these in a timely manner. Responsibilities: Manage and support the Hollister SharePoint environment Provide support and ad-hoc training for SharePoint 2013 and to assist with the resolution of Tire1 and 2 IT Service Desk support calls Support and advise users in their day-to-day use of Microsoft SharePoint 2013 - providing one to one or group training when necessary Work with the Digital Business and Web Development teams on the resolution of any problems exhibited by existing web-based applications and services Provides guidance to business units on structure of their SharePoint team or project sites Implements out-of-the-box workflow to automate business processes Assists in creating customer training material Assist customers in building new and customizing existing SharePoint pages Assist customers with all aspects of SharePoint usage including team site development, item sharing, site structures, searching, meta data, and file management Provision and de-provision SharePoint resources and web-sites per user requests Perform administration of SharePoint and active directory to facilitate approved Associate access to SharePoint resources Test and install security and functional updates, minor releases, and service packs as recommended by vendors to keep SharePoint and third party components up to date Make recommendations regarding new technologies and their uses to management Effectively partners with other IT groups to deliver IT services. Participates in key process improvements as they relate to the network environment. Collaborates with systems engineering, business application, and database architecture functions to ensure availability, reliability, and scalability of the corporate network infrastructure to meet business needs. Ability to communicate effectively with Associates at all levels. Maintains working knowledge of business and technology and remains current with emerging industry trends. Establishes and tracks appropriate metrics and key performance indicators. Implements processes, tools, and supports ongoing service level measurement metrics and reporting. Maintains and supports processes and ensures ongoing communication of such processes to internal teams and business customers. Identifies avenues for continuous improvement for services within scope of responsibility, including new approaches and processes that would contribute to improvements within department and to business growth/efficiency in the wider organization. Assist with the development of policies, procedures, and technologies. Provides business consulting and technical support to all business areas globally. Utilizes incident management tool for entries on SharePoint related issues; prioritizes, responds to, and resolves as appropriate. Escalates issues; engages vendor support; provides timely response to customer escalations. Participates in data center disaster recovery planning and execution. Provide customer training. Create and maintain system, operations, and customer documentation. Create and maintain design and test documentation in accordance with established methodology and standards. Performs other duties as assigned Requirements: BS/BA Computer Science or equivalent related field of study preferred. Specific vendor certifications desired (MCSE:SharePoint). 3-7 years overall experience is required Progressive technical IT experience concentrating on SharePoint technologies. Knowledge of Microsoft Windows Active Directory. Deep knowledge of integration of SharePoint solutions with other applications is required Experience with workflow set up and design Understanding of Office 365 Talk on phone with supplies and Hollister Associates Read technical manuals / trade journals Use a personal computer with a strong proficiency in PowerPoint, Word and Excel Travel via airplane or automobile Lift up to 40 lbs. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 28237 Apply Now!
Mar 30, 2020
Full time
We Make Life More Rewarding and Dignified Location: Libertyville Department: Information Technology Summary: The role of the Specialist SharePoint Super User is to provide customer support, customizing and troubleshooting of existing SharePoint pages. This will include out-of-the-box workflow automation to support the business as well as creating and maintaining customer documentation and training. The Specialist SharePoint Support will work with internal Information Technology teams to resolve issues and questions with current web-based applications and services. This also includes supporting and maintaining third-party add-ons to the SharePoint environment. The Specialist SharePoint Support will address a multitude of requests and issues from customers in regards to their team and project sites and will be able to address these in a timely manner. Responsibilities: Manage and support the Hollister SharePoint environment Provide support and ad-hoc training for SharePoint 2013 and to assist with the resolution of Tire1 and 2 IT Service Desk support calls Support and advise users in their day-to-day use of Microsoft SharePoint 2013 - providing one to one or group training when necessary Work with the Digital Business and Web Development teams on the resolution of any problems exhibited by existing web-based applications and services Provides guidance to business units on structure of their SharePoint team or project sites Implements out-of-the-box workflow to automate business processes Assists in creating customer training material Assist customers in building new and customizing existing SharePoint pages Assist customers with all aspects of SharePoint usage including team site development, item sharing, site structures, searching, meta data, and file management Provision and de-provision SharePoint resources and web-sites per user requests Perform administration of SharePoint and active directory to facilitate approved Associate access to SharePoint resources Test and install security and functional updates, minor releases, and service packs as recommended by vendors to keep SharePoint and third party components up to date Make recommendations regarding new technologies and their uses to management Effectively partners with other IT groups to deliver IT services. Participates in key process improvements as they relate to the network environment. Collaborates with systems engineering, business application, and database architecture functions to ensure availability, reliability, and scalability of the corporate network infrastructure to meet business needs. Ability to communicate effectively with Associates at all levels. Maintains working knowledge of business and technology and remains current with emerging industry trends. Establishes and tracks appropriate metrics and key performance indicators. Implements processes, tools, and supports ongoing service level measurement metrics and reporting. Maintains and supports processes and ensures ongoing communication of such processes to internal teams and business customers. Identifies avenues for continuous improvement for services within scope of responsibility, including new approaches and processes that would contribute to improvements within department and to business growth/efficiency in the wider organization. Assist with the development of policies, procedures, and technologies. Provides business consulting and technical support to all business areas globally. Utilizes incident management tool for entries on SharePoint related issues; prioritizes, responds to, and resolves as appropriate. Escalates issues; engages vendor support; provides timely response to customer escalations. Participates in data center disaster recovery planning and execution. Provide customer training. Create and maintain system, operations, and customer documentation. Create and maintain design and test documentation in accordance with established methodology and standards. Performs other duties as assigned Requirements: BS/BA Computer Science or equivalent related field of study preferred. Specific vendor certifications desired (MCSE:SharePoint). 3-7 years overall experience is required Progressive technical IT experience concentrating on SharePoint technologies. Knowledge of Microsoft Windows Active Directory. Deep knowledge of integration of SharePoint solutions with other applications is required Experience with workflow set up and design Understanding of Office 365 Talk on phone with supplies and Hollister Associates Read technical manuals / trade journals Use a personal computer with a strong proficiency in PowerPoint, Word and Excel Travel via airplane or automobile Lift up to 40 lbs. Hollister is an EO employer - M/F/Veteran/Disability Job Req ID: 28237 Apply Now!
We Make Life More Rewarding and Dignified Location: Libertyville Department: Information Technology Summary: As Director, Information Security & Cyber Risk Management you will be responsible for the information security of Hollister's customers and Associates. You will direct and lead Hollister's Information Security and Cyber Risk Management program globally, developing appropriate security controls for business partners and service providers. You will ensure IT strategies, practices and principles have a strong emphasis on security, while also ensuring that new products and solutions meet business requirements while maintaining a strong security posture. You will also direct day to day security administrative activities ensuring the stable and secure operations of IT and related systems and components. You will ensure security compliance through audits, risk assessments and issue management in order to maintain a compliant, audit ready posture. This role also acts as a core team member of the Hollister Technical Review Board and the overall Global IT Leadership team. You will also proactively work across the enterprise including sister companies as needed to ensure threat indicators are rated by severity and responded to in a manner consistent with the threat. You will also develop security policies and procedures for our global affiliated companies. This individual will have 2-3 direct reports and travel around 10% of the time. Responsibilities: Direct the enterprise-wide information security function to ensure consistent and high-quality information security management in support of business goals. Develop, manage and improve a comprehensive information security risk-based program to ensure the integrity, confidentiality and availability of information assets. Identify, assess, and prioritize IT risks to data and systems, including external threats, cyber-crimes, internal threats and third-party risks. Advise relevant stakeholders on the appropriate courses of action to mitigate or eliminate risk. Responsible for definition of the security architecture for cloud technologies. Provides security thought leadership across cloud domains and assures seamless integration into the enterprise security and risk framework. Assist in the definition of the strategy for overall cloud security functions. Provide strategic risk guidance and consultation for all Hollister projects, including the evaluation and recommendation of technical standards and controls. Coordinate the development of implementation plans and procedures to ensure that business-critical services are recovered in the event of a security or disaster event. Lead Identity and Access Management (IAM) projects, including those involving Authoritative Source, Identity Management, Provisioning, Authentication, Authorization, Monitoring and Certifications, and Auditing and Reporting Identifies Information Security and Cyber Risk Management and compliance requirements Builds solution architectures that meet Enterprise requirements and align with architecture principles and future architecture vision. Partners with the Enterprise Architecture function to provide technology evaluations and recommendations relating to Information Security and Cyber Risk Management. Participates as a core project team member as required. Develops and maintains the Information Security and Cyber Risk Management architecture. Enhances guiding principles and technical standards that guide technology decisions. Develop and maintain an IT security architecture roadmap that will identify security controls and identify and assess current and new technologies that will enforce the organization's security priorities. Collaborates with business unit leadership to understand the requirements for security (stability, availability, integrity, privacy etc.). Directs and approves the design of information security systems and performs annual information security risk assessment. Leads security and privacy compliance and assurance monitoring. Sponsors audits and monitors issues to provide assurance reporting of how Hollister is complying with specific country and industry regulatory requirements and the internal control framework in order to maintain a compliant, audit ready, posture. Identifies and implements appropriate security and privacy monitoring within IT to safeguard Hollister's security program. Acts as a focal point for remediating IT related security or data management issues. Accountable for security and privacy impact assessments to determine the enterprise's specific security and privacy related requirements and to identify and address potential vulnerabilities. Maintains a risk management framework to ensure that security decisions are consistent and appropriate to Hollister's needs for system and information protection, integrity, availability, privacy and regulatory compliance. Ensures that risk assessments are performed for the introduction of new technologies. Review and approve the findings and recommendation of risk assessments. Direct and augment current Associate Outreach, Education and Training processes. Enhances education and awareness programs and advises departments on all levels on security issues, best practices, and vulnerabilities. Pursues security initiatives to address unique needs in protecting corporate infrastructure. Monitors the external threat environment for emerging threats, and advises relevant stakeholders on the appropriate courses of action. Coordinates information security projects with resources from IT and business unit teams. Reviews and processes Technical Review Board (TRB) requests for new hardware, software or technology solutions. Participates in TRB as a core team member, providing Information Security and Cyber Risk Management leadership. Attends all TRB meetings, provides feedback and act as an approver of the proposed solution. Represent security and data privacy concerns. Identifies new solutions, architectures or technologies for review at the meeting. Prepares appropriate deliverables for review prior to each meeting. Brings forward new IT projects that will transition the architecture to the denied future vision. Builds the initial business case and define scope and objectives. Works with a Project Director(s) to develop cost, resource, and schedule estimates. Applies risk based approach or value metrics to define project priorities. Escalates issues and risks as appropriate. Manages and develops team and systems in area of responsibility including all aspects of the company's performance management process Develops and Directors direct report and resource levels to effectively meet business needs Manages and continually evaluates security processes and methods to ensure effective, efficient delivery of Information Security and Cyber Risk Management. Prioritizing and responding to team assigned tickets as appropriate. Oversees and maintains enterprise security systems including: Configuring and supporting end point protection Configuring and supporting Information Security and Cyber Risk Management detection and prevention systems Appropriate and timely system patching to ensure effective Information Security and Cyber Risk Management controls Requirements: BS/BA Computer Science or equivalent related field of study required. An industry leading security certification required such as Certified Information Systems Security Professional (CISSP) or equivalent. Minimum of 15 years of diverse and progressive IT experience Minimum 10 years Information Security and Cyber Risk Management leadership experience Minimum 7 years people management experience Experience in Cloud and Privacy. Passion for technology and technical depth to uncover root causes of complex technical problems and provide guidance on solving them. Ability to build relationships and lead through influence, both with internal and external stakeholders. Ability to inspire and motivate a Security Engineering team to work together as a cohesive and highly productive unit. Ability to provide detailed technical guidance to the team, enabling them to execute more effectively and deliver products on time and within budget. Excellent communication skills with the ability to act as a thought leader in strategy discussions. Knowledge and demonstrated experience of relevant legal and regulatory requirements, such as HIPAA Privacy & Security, GDPR and other CMS regulations and guidelines. Knowledge of common information security management frameworks. Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do..... click apply for full job details
Mar 30, 2020
Full time
We Make Life More Rewarding and Dignified Location: Libertyville Department: Information Technology Summary: As Director, Information Security & Cyber Risk Management you will be responsible for the information security of Hollister's customers and Associates. You will direct and lead Hollister's Information Security and Cyber Risk Management program globally, developing appropriate security controls for business partners and service providers. You will ensure IT strategies, practices and principles have a strong emphasis on security, while also ensuring that new products and solutions meet business requirements while maintaining a strong security posture. You will also direct day to day security administrative activities ensuring the stable and secure operations of IT and related systems and components. You will ensure security compliance through audits, risk assessments and issue management in order to maintain a compliant, audit ready posture. This role also acts as a core team member of the Hollister Technical Review Board and the overall Global IT Leadership team. You will also proactively work across the enterprise including sister companies as needed to ensure threat indicators are rated by severity and responded to in a manner consistent with the threat. You will also develop security policies and procedures for our global affiliated companies. This individual will have 2-3 direct reports and travel around 10% of the time. Responsibilities: Direct the enterprise-wide information security function to ensure consistent and high-quality information security management in support of business goals. Develop, manage and improve a comprehensive information security risk-based program to ensure the integrity, confidentiality and availability of information assets. Identify, assess, and prioritize IT risks to data and systems, including external threats, cyber-crimes, internal threats and third-party risks. Advise relevant stakeholders on the appropriate courses of action to mitigate or eliminate risk. Responsible for definition of the security architecture for cloud technologies. Provides security thought leadership across cloud domains and assures seamless integration into the enterprise security and risk framework. Assist in the definition of the strategy for overall cloud security functions. Provide strategic risk guidance and consultation for all Hollister projects, including the evaluation and recommendation of technical standards and controls. Coordinate the development of implementation plans and procedures to ensure that business-critical services are recovered in the event of a security or disaster event. Lead Identity and Access Management (IAM) projects, including those involving Authoritative Source, Identity Management, Provisioning, Authentication, Authorization, Monitoring and Certifications, and Auditing and Reporting Identifies Information Security and Cyber Risk Management and compliance requirements Builds solution architectures that meet Enterprise requirements and align with architecture principles and future architecture vision. Partners with the Enterprise Architecture function to provide technology evaluations and recommendations relating to Information Security and Cyber Risk Management. Participates as a core project team member as required. Develops and maintains the Information Security and Cyber Risk Management architecture. Enhances guiding principles and technical standards that guide technology decisions. Develop and maintain an IT security architecture roadmap that will identify security controls and identify and assess current and new technologies that will enforce the organization's security priorities. Collaborates with business unit leadership to understand the requirements for security (stability, availability, integrity, privacy etc.). Directs and approves the design of information security systems and performs annual information security risk assessment. Leads security and privacy compliance and assurance monitoring. Sponsors audits and monitors issues to provide assurance reporting of how Hollister is complying with specific country and industry regulatory requirements and the internal control framework in order to maintain a compliant, audit ready, posture. Identifies and implements appropriate security and privacy monitoring within IT to safeguard Hollister's security program. Acts as a focal point for remediating IT related security or data management issues. Accountable for security and privacy impact assessments to determine the enterprise's specific security and privacy related requirements and to identify and address potential vulnerabilities. Maintains a risk management framework to ensure that security decisions are consistent and appropriate to Hollister's needs for system and information protection, integrity, availability, privacy and regulatory compliance. Ensures that risk assessments are performed for the introduction of new technologies. Review and approve the findings and recommendation of risk assessments. Direct and augment current Associate Outreach, Education and Training processes. Enhances education and awareness programs and advises departments on all levels on security issues, best practices, and vulnerabilities. Pursues security initiatives to address unique needs in protecting corporate infrastructure. Monitors the external threat environment for emerging threats, and advises relevant stakeholders on the appropriate courses of action. Coordinates information security projects with resources from IT and business unit teams. Reviews and processes Technical Review Board (TRB) requests for new hardware, software or technology solutions. Participates in TRB as a core team member, providing Information Security and Cyber Risk Management leadership. Attends all TRB meetings, provides feedback and act as an approver of the proposed solution. Represent security and data privacy concerns. Identifies new solutions, architectures or technologies for review at the meeting. Prepares appropriate deliverables for review prior to each meeting. Brings forward new IT projects that will transition the architecture to the denied future vision. Builds the initial business case and define scope and objectives. Works with a Project Director(s) to develop cost, resource, and schedule estimates. Applies risk based approach or value metrics to define project priorities. Escalates issues and risks as appropriate. Manages and develops team and systems in area of responsibility including all aspects of the company's performance management process Develops and Directors direct report and resource levels to effectively meet business needs Manages and continually evaluates security processes and methods to ensure effective, efficient delivery of Information Security and Cyber Risk Management. Prioritizing and responding to team assigned tickets as appropriate. Oversees and maintains enterprise security systems including: Configuring and supporting end point protection Configuring and supporting Information Security and Cyber Risk Management detection and prevention systems Appropriate and timely system patching to ensure effective Information Security and Cyber Risk Management controls Requirements: BS/BA Computer Science or equivalent related field of study required. An industry leading security certification required such as Certified Information Systems Security Professional (CISSP) or equivalent. Minimum of 15 years of diverse and progressive IT experience Minimum 10 years Information Security and Cyber Risk Management leadership experience Minimum 7 years people management experience Experience in Cloud and Privacy. Passion for technology and technical depth to uncover root causes of complex technical problems and provide guidance on solving them. Ability to build relationships and lead through influence, both with internal and external stakeholders. Ability to inspire and motivate a Security Engineering team to work together as a cohesive and highly productive unit. Ability to provide detailed technical guidance to the team, enabling them to execute more effectively and deliver products on time and within budget. Excellent communication skills with the ability to act as a thought leader in strategy discussions. Knowledge and demonstrated experience of relevant legal and regulatory requirements, such as HIPAA Privacy & Security, GDPR and other CMS regulations and guidelines. Knowledge of common information security management frameworks. Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do..... click apply for full job details
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Automation Engineer provides technical leadership to the automation team at our gene therapy manufacturing facility. Responsibilities Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention. Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, BMS, 3 rd party local control systems, freezers, air handlers and chillers. Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines. Develop project objectives working with user requirement and business plans. Finish Determine equipment or system specifications and most cost-effective technology to be implemented. Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools. Responsible for maintaining procedures to meet GMP requirements, CFR's and internal company policies. Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing. Drive operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Problem solve any technically related issues impacting production. Support 24x7 site-based operations after startup. Create and update procedures to drive operational efficiency and compliance. Implement and revise SOPs to conform with standards and policies. Deploy, maintain, and upgrade manufacturing applications. Perform investigations of non-conformances related to automation systems. Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations. Execute change controls to update and upgrade automation systems and equipment. Qualifications BS. degree in Engineering, Computer Science, or related technical field. 8 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish. Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV). Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7). Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian). Experience in system level validation testing. Proven experience applying S88 in an automated environment. Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation. Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc. Experience writing and executing change controls. Able to develop MS SQL queries. In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products. Excellent oral and written communication skills. Experience managing 3 rd parties (both in-sourcing and outsourcing). Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. Provide technical support on all manufacturing issues when driving towards issue resolution. 10 - 50% travel may be required. This position will be located out of our Libertyville IL office. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Mar 30, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Automation Engineer provides technical leadership to the automation team at our gene therapy manufacturing facility. Responsibilities Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention. Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, BMS, 3 rd party local control systems, freezers, air handlers and chillers. Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines. Develop project objectives working with user requirement and business plans. Finish Determine equipment or system specifications and most cost-effective technology to be implemented. Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools. Responsible for maintaining procedures to meet GMP requirements, CFR's and internal company policies. Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing. Drive operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Problem solve any technically related issues impacting production. Support 24x7 site-based operations after startup. Create and update procedures to drive operational efficiency and compliance. Implement and revise SOPs to conform with standards and policies. Deploy, maintain, and upgrade manufacturing applications. Perform investigations of non-conformances related to automation systems. Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations. Execute change controls to update and upgrade automation systems and equipment. Qualifications BS. degree in Engineering, Computer Science, or related technical field. 8 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish. Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV). Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7). Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian). Experience in system level validation testing. Proven experience applying S88 in an automated environment. Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation. Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc. Experience writing and executing change controls. Able to develop MS SQL queries. In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products. Excellent oral and written communication skills. Experience managing 3 rd parties (both in-sourcing and outsourcing). Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. Provide technical support on all manufacturing issues when driving towards issue resolution. 10 - 50% travel may be required. This position will be located out of our Libertyville IL office. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
Description We believe in diligently working to understand and serve customers to meet their financial security needs. This is why we exist. The Career Basics We're looking for insurance sales agents focused on building a network, finding prospective customers and helping ensure those customers are protected financially in whatever circumstances may arise. We offer insurance sales agents: a competitive compensation plan. In addition to a base salary, you'll be eligible to receive commissions, incentives, trips & rewards. access to benefits like health, vision, dental and disability insurance. We believe before you can help others feel secure, you need to feel that way too! access to the tools you need to serve customers and do successful work, such as a comprehensive training program, marketing and office support. The Ideal Sales Agent At COUNTRY Financial, the ideal insurance sales agent is someone who: proactively communicates with customers and is responsive to their unique needs. values transparency and honesty, always investing in customer relationships. listens to the customer and seeks to understand customers and their families shares their expertise to help educate customers and build trust-especially in new relationships. makes it easy for customers to understand what they're saying and why it matters. Qualifications What You Will Need While these insurance licenses are not required to apply, your ability to obtain them is essential when a hiring decision is made: Property/Casualty State Insurance License* Life/Health State Insurance License* Why Should You Apply? COUNTRY Financial is an organization that is trusted and well-respected in the industry, with a history of success and great ratings. You can make a difference in people's lives while maintaining the flexibility and freedom to do what matters in your own life-we think that's a win. Incredible training from our team will be the first step in your on-boarding process. We want to be sure you're equipped for success! About Us The Organization: COUNTRY Financial® is the trade name for a family of affiliated companies-this means we have a whole family of support and a large backing. Our roots are in agriculture, so we're hardworking and known for the great care we take with customers and employees alike. We are a growing insurance and financial services organization privately serving 19 states across the nation. Our home offices are in Bloomington, IL, with a Southern Office hub in Alpharetta, GA and a Western Office in Salem, OR. Most importantly, we serve over 1 million households in the United States and pride ourselves on putting the customer first. COUNTRY Financial® is an Equal Opportunity Employer . We are committed to provide equal opportunity in all areas of employment and support a diverse workforce and an inclusive work environment.
Mar 30, 2020
Full time
Description We believe in diligently working to understand and serve customers to meet their financial security needs. This is why we exist. The Career Basics We're looking for insurance sales agents focused on building a network, finding prospective customers and helping ensure those customers are protected financially in whatever circumstances may arise. We offer insurance sales agents: a competitive compensation plan. In addition to a base salary, you'll be eligible to receive commissions, incentives, trips & rewards. access to benefits like health, vision, dental and disability insurance. We believe before you can help others feel secure, you need to feel that way too! access to the tools you need to serve customers and do successful work, such as a comprehensive training program, marketing and office support. The Ideal Sales Agent At COUNTRY Financial, the ideal insurance sales agent is someone who: proactively communicates with customers and is responsive to their unique needs. values transparency and honesty, always investing in customer relationships. listens to the customer and seeks to understand customers and their families shares their expertise to help educate customers and build trust-especially in new relationships. makes it easy for customers to understand what they're saying and why it matters. Qualifications What You Will Need While these insurance licenses are not required to apply, your ability to obtain them is essential when a hiring decision is made: Property/Casualty State Insurance License* Life/Health State Insurance License* Why Should You Apply? COUNTRY Financial is an organization that is trusted and well-respected in the industry, with a history of success and great ratings. You can make a difference in people's lives while maintaining the flexibility and freedom to do what matters in your own life-we think that's a win. Incredible training from our team will be the first step in your on-boarding process. We want to be sure you're equipped for success! About Us The Organization: COUNTRY Financial® is the trade name for a family of affiliated companies-this means we have a whole family of support and a large backing. Our roots are in agriculture, so we're hardworking and known for the great care we take with customers and employees alike. We are a growing insurance and financial services organization privately serving 19 states across the nation. Our home offices are in Bloomington, IL, with a Southern Office hub in Alpharetta, GA and a Western Office in Salem, OR. Most importantly, we serve over 1 million households in the United States and pride ourselves on putting the customer first. COUNTRY Financial® is an Equal Opportunity Employer . We are committed to provide equal opportunity in all areas of employment and support a diverse workforce and an inclusive work environment.
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The successful candidate will be responsible for the Quality oversight of manufacturing operations on the floor and working in collaboration with AveXis staff. Responsiblities include but are not limited to the following: review and approve written procedures, on the floor batch record documentation review, monitor and control the manufacturing environment, plant hygiene, process validation, people/process/waste flow patterns, aseptic certification, nonconformance review/disposition, and monitoring compliance with all requirements of good manufacturing practice. The Manufacturing Quality Associate is responsible for supporting the design and implementation of robust Quality Systems for a new viral gene manufacturing site and quality on the manufacturing floor. The Manufacturing Quality Associate will be responsible for quality related business systems such as non-conformance/CAPA, by contributing and reviewing for approval and assisting with the implementation and supporting on-going continuous improvements. The Manufacturing Associate will use risk based decision to address any issues on the Manufacturing floor and will serve as the quality point of contact for the operations. Will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a good knowledge of and application of the CFR's and cGMP's . Responsibilities Complete on the floor quality audits and sampling during the manufacturing processes; knowledge of AQLs and visual inspection preferred Good understanding of batch record execution, GMP and GDP. Knowledge of upstream and downstream processing necessary. Work effectively with operators on the floor and make on the spot, risk based decisions; escalate issues to management as necessary Assist in developing and delivering robust overall quality systems resulting ina fully compliant facility with respect to procedures and processes Contribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics; reporting to management all necessary information from plant floor Provide support on quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA's) and critical processing parameters (CPP's) Support and review of SOPs/Document Management: documentation management and SOPs all instruction sets, specifications, batch records etc. and other Quality procedures directly related to operations and other cGMP activities o On the floor Batch record review. Ability to review controlled documentation during processing for GMP and GDP Non-conformance/CAPA Management support and initial review of Non-conformances and CAPAs Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans and assist in determining a root cause o In process sampling/ AQL sampling Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product Qualifications Minimum B.S. degree in preferably microbiology, chemistry or biochemistry or 5 years applicable industry experience A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish Experience with viral gene therapies and/or orphan disease indications is a plus Knowledge of FDA regulations and experience in US and international regulatory agency inspections Direct experience reviewing standard operating procedures and partnering with operations on product related investigations and Non-conformances Excellent oral and written communication skills with strong technical writing experience required Experience with internal audits responsibilities and activities may change at any time with or without notice. Willing to work off-shift hours as directed. This position will be located out of our Chicago area office. Limited travel. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-TM1
Mar 30, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The successful candidate will be responsible for the Quality oversight of manufacturing operations on the floor and working in collaboration with AveXis staff. Responsiblities include but are not limited to the following: review and approve written procedures, on the floor batch record documentation review, monitor and control the manufacturing environment, plant hygiene, process validation, people/process/waste flow patterns, aseptic certification, nonconformance review/disposition, and monitoring compliance with all requirements of good manufacturing practice. The Manufacturing Quality Associate is responsible for supporting the design and implementation of robust Quality Systems for a new viral gene manufacturing site and quality on the manufacturing floor. The Manufacturing Quality Associate will be responsible for quality related business systems such as non-conformance/CAPA, by contributing and reviewing for approval and assisting with the implementation and supporting on-going continuous improvements. The Manufacturing Associate will use risk based decision to address any issues on the Manufacturing floor and will serve as the quality point of contact for the operations. Will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a good knowledge of and application of the CFR's and cGMP's . Responsibilities Complete on the floor quality audits and sampling during the manufacturing processes; knowledge of AQLs and visual inspection preferred Good understanding of batch record execution, GMP and GDP. Knowledge of upstream and downstream processing necessary. Work effectively with operators on the floor and make on the spot, risk based decisions; escalate issues to management as necessary Assist in developing and delivering robust overall quality systems resulting ina fully compliant facility with respect to procedures and processes Contribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics; reporting to management all necessary information from plant floor Provide support on quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA's) and critical processing parameters (CPP's) Support and review of SOPs/Document Management: documentation management and SOPs all instruction sets, specifications, batch records etc. and other Quality procedures directly related to operations and other cGMP activities o On the floor Batch record review. Ability to review controlled documentation during processing for GMP and GDP Non-conformance/CAPA Management support and initial review of Non-conformances and CAPAs Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans and assist in determining a root cause o In process sampling/ AQL sampling Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product Qualifications Minimum B.S. degree in preferably microbiology, chemistry or biochemistry or 5 years applicable industry experience A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish Experience with viral gene therapies and/or orphan disease indications is a plus Knowledge of FDA regulations and experience in US and international regulatory agency inspections Direct experience reviewing standard operating procedures and partnering with operations on product related investigations and Non-conformances Excellent oral and written communication skills with strong technical writing experience required Experience with internal audits responsibilities and activities may change at any time with or without notice. Willing to work off-shift hours as directed. This position will be located out of our Chicago area office. Limited travel. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-TM1
