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 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 Change Control Specialist is responsible for the initiation, management, and completion of change control records focusing primarily on changes associated with process and product related elements of the manufacturing operations. Responsibilities Initiate, own, and drive complex change controls related to manufacturing operations -including multi-site and phased implementations. Communicate, collaborate, and partner with a wide variety of stakeholders; Manufacturing staff, Manufacturing, Science, and Technology (MSAT), engineering disciplines, Quality Assurance, Facilities, Utilities, Maintenance, and Management. Act as an empowered member of the Change Control Review Board (CCRB) both locally as well as at the network level. Upon NC/CAPA certification, own and author investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering, as required. Maintain a presence on the manufacturing floor for data gathering, observing of processes for insight related to pending changes, investigations, and interviewing employees, as required. Conduct personnel interviews and system reviews as an element of change control scoping. Understand appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams). Upon NC/CAPA certification, assign and implement proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events. Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to change control path forward. Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of critical records. Remain current in regulatory expectations and industry practices regarding best practices in change control and change management, investigations, and CAPAs. Management of multiple projects and timelines concurrently. Adhere to standard timelines and escalate actions appropriately for resolution in a timely manner. Perform and conduct risk assessments, as required. Support the continuous improvement program for the manufacturing process. Provide coordination of activities relating to Continuous Improvement and enhancing knowledge of the tools and techniques of Continuous Improvement / Lean methods. Support strategic proposals, progress updates and presentations to all levels of the site organization. Project management of small projects. Other related duties as assigned. Qualifications Bachelor's degree (preferred) in a life Science (or relevant liberal arts degree) and 6 years of experience in manufacturing or 9 years of experience in a manufacturing without a bachelors' degree. Prior experience in managing change control records and understanding change management methods and standard practices. Possess highly-developed technical writing skills - and the ability to communicate in a clear and succinct manner. Proven ability to work in a fast paced, high workload environment, and manage multiple projects and objectives for on-time event closure. 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 adaptable to change. Proven ability to identify and flag risks in a timely manner to keep deliverables on track. Strong communication skills both verbally and written. Proven logic and decision-making abilities and critical thinking skills. Ability to accommodate manufacturing schedule as required. Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills. Preferred - PowerBI experience. Preferred - Prior experience in Nonconformance & CAPA authoring and ownership. Preferred - GMP Manufacturing experience, specifically upstream and downstream processing. Preferred - Six Sigma Yellow, Green or Black Belt certification. 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-JB1
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 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 Change Control Specialist is responsible for the initiation, management, and completion of change control records focusing primarily on changes associated with process and product related elements of the manufacturing operations. Responsibilities Initiate, own, and drive complex change controls related to manufacturing operations -including multi-site and phased implementations. Communicate, collaborate, and partner with a wide variety of stakeholders; Manufacturing staff, Manufacturing, Science, and Technology (MSAT), engineering disciplines, Quality Assurance, Facilities, Utilities, Maintenance, and Management. Act as an empowered member of the Change Control Review Board (CCRB) both locally as well as at the network level. Upon NC/CAPA certification, own and author investigation reports related to cell culture, purification, formulation, filling, inspection, packaging, facilities and engineering, as required. Maintain a presence on the manufacturing floor for data gathering, observing of processes for insight related to pending changes, investigations, and interviewing employees, as required. Conduct personnel interviews and system reviews as an element of change control scoping. Understand appropriate root-cause analysis for events utilizing investigation tools (e.g., 5 Whys, Fishbone Diagrams). Upon NC/CAPA certification, assign and implement proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events. Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed to change control path forward. Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of critical records. Remain current in regulatory expectations and industry practices regarding best practices in change control and change management, investigations, and CAPAs. Management of multiple projects and timelines concurrently. Adhere to standard timelines and escalate actions appropriately for resolution in a timely manner. Perform and conduct risk assessments, as required. Support the continuous improvement program for the manufacturing process. Provide coordination of activities relating to Continuous Improvement and enhancing knowledge of the tools and techniques of Continuous Improvement / Lean methods. Support strategic proposals, progress updates and presentations to all levels of the site organization. Project management of small projects. Other related duties as assigned. Qualifications Bachelor's degree (preferred) in a life Science (or relevant liberal arts degree) and 6 years of experience in manufacturing or 9 years of experience in a manufacturing without a bachelors' degree. Prior experience in managing change control records and understanding change management methods and standard practices. Possess highly-developed technical writing skills - and the ability to communicate in a clear and succinct manner. Proven ability to work in a fast paced, high workload environment, and manage multiple projects and objectives for on-time event closure. 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 adaptable to change. Proven ability to identify and flag risks in a timely manner to keep deliverables on track. Strong communication skills both verbally and written. Proven logic and decision-making abilities and critical thinking skills. Ability to accommodate manufacturing schedule as required. Strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills. Preferred - PowerBI experience. Preferred - Prior experience in Nonconformance & CAPA authoring and ownership. Preferred - GMP Manufacturing experience, specifically upstream and downstream processing. Preferred - Six Sigma Yellow, Green or Black Belt certification. 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-JB1
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-MG1
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-MG1
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. We are seeking a highly motivated individual to join us as a Quality Control Senior Microbiologist. You will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. This role will be a hands-on resource reporting to the QC Director of Microbiology. In this role you will be responsible for providing quality control technical support to QC and Manufacturing. Responsibilities Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability). Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state. Develop, revise and review SOPs, qualification/validation protocols and reports. Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures. Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Gather metric information for use in continuous improvement of areas of responsibility. Train staff on technical concepts and methods. Review laboratory data. Perform other duties as assigned. Role Specific Responsibilities and Preferred Skills: Experience performing gap assessment against company Policies and building subsequent implementation plans Experience providing broad technical oversight to define and implement new programs and technologies within QC Microbiology Extensive experience mentoring and developing team members Experience in regulatory inspections and internal audits as subject matter expert for various microbiological programs Extensive experience in a drug product/aseptic processing environment Practical laboratory experience with adventitious agent testing methodologies and execution Extensive experience designing and implementing QC microbiological programs in support of a GMP Quality Control laboratory and manufacturing center Strong working knowledge and demonstrated experience in a variety of QC Microbiology programs, such as environmental/utility monitoring, Aseptic Process validation and monitoring, microbial identification, and other applicable methods to the testing of biopharmaceuticals Experience utilizing and assessing data from statistical analysis software programs Experience authoring and analyzing trending reports related to various microbiology programs Experience operating effectively and respectfully at the site and network level Qualifications Bachelor's degree or advanced degree in Microbiology or related discipline. A minimum of 8 years' experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years' experience with method and equipment validation within the biotechnology or pharmaceutical industry. The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs. The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell and gene therapy products. Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/, ISO 14644-1, USP, EP). Experience in performing risk assessments. Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation. Extensive experience in conducting laboratory and environmental excursion investigations. Strong knowledge of Equipment IQ/OQ/PQ/PV. Proficient in MS Word, Excel, Power Point and other applications. Ability to communicate and work independently with scientific/technical personnel. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Excellent interpersonal, verbal and written communication skills. Experience managing projects. Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently. 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-MG1
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. We are seeking a highly motivated individual to join us as a Quality Control Senior Microbiologist. You will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. This role will be a hands-on resource reporting to the QC Director of Microbiology. In this role you will be responsible for providing quality control technical support to QC and Manufacturing. Responsibilities Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability). Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state. Develop, revise and review SOPs, qualification/validation protocols and reports. Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures. Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Gather metric information for use in continuous improvement of areas of responsibility. Train staff on technical concepts and methods. Review laboratory data. Perform other duties as assigned. Role Specific Responsibilities and Preferred Skills: Experience performing gap assessment against company Policies and building subsequent implementation plans Experience providing broad technical oversight to define and implement new programs and technologies within QC Microbiology Extensive experience mentoring and developing team members Experience in regulatory inspections and internal audits as subject matter expert for various microbiological programs Extensive experience in a drug product/aseptic processing environment Practical laboratory experience with adventitious agent testing methodologies and execution Extensive experience designing and implementing QC microbiological programs in support of a GMP Quality Control laboratory and manufacturing center Strong working knowledge and demonstrated experience in a variety of QC Microbiology programs, such as environmental/utility monitoring, Aseptic Process validation and monitoring, microbial identification, and other applicable methods to the testing of biopharmaceuticals Experience utilizing and assessing data from statistical analysis software programs Experience authoring and analyzing trending reports related to various microbiology programs Experience operating effectively and respectfully at the site and network level Qualifications Bachelor's degree or advanced degree in Microbiology or related discipline. A minimum of 8 years' experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years' experience with method and equipment validation within the biotechnology or pharmaceutical industry. The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs. The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell and gene therapy products. Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/, ISO 14644-1, USP, EP). Experience in performing risk assessments. Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation. Extensive experience in conducting laboratory and environmental excursion investigations. Strong knowledge of Equipment IQ/OQ/PQ/PV. Proficient in MS Word, Excel, Power Point and other applications. Ability to communicate and work independently with scientific/technical personnel. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Excellent interpersonal, verbal and written communication skills. Experience managing projects. Experience drafting qualification/validation protocols and reports. Experience executing equipment and method qualifications independently. 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-MG1
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 Analytical Science and Technology (AST) Scientist provides support for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation. As gene therapy is still an emerging/fast progressing field, passion for continuous learning and capability to work in a highly dynamic, fast pace, collaborative environment is key to the success of this role. Responsibilities Perform lab experiments with oversight/guidance. Oversee method transfer, qualification/validation, trending across analytical network. Act as analytical technical lead for one or more projects with guidance. Work closely with Analytical Development group to transfer/co-qualify new methods. Collaborate with contract testing labs to ensure successful completion of projects to the standards of AveXis. Assist with authoring experimental protocols/reports and regulatory submissions related to analytical. Participate in assay troubleshooting and projects to improve method performance across network. Support OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions. Assist with responses to agency questions related to analytical methods/specification. Manage the use and maintenance of scientific equipment and instrumentation, computer systems. Qualifications BS with 4+ years' biopharmaceutical experience; MS with 2+ years' biopharmaceutical experience; Ph.D. Strong critical thinking and problem-solving skills. Experience with method development, transfer, qualification and validation. Experience in gene/cell therapy field is a plus. Must possess knowledge of some of the following: general protein/nucleic acid chemistry/biochemistry, basic molecular biology, basic understanding of GMP requirement and regulations (FDA/EMA/ICH etc.), Chromatography (RP, SEC, IEX, HILIC etc.), ELISA, cell based bioassay (potency, infectious titer assay etc.), PCR (qPCR, ddPCR etc.), analytical ultracentrifugation, spectroscopy (UV, fluorescence, FTIR), mass spectrometry (esp. ICP-MS), particle analysis. An excellent and persuasive communicator. Energetic, flexible, collaborative and proactive. Strong communication, scientific writing and presentation skills. 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-MG1
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 Analytical Science and Technology (AST) Scientist provides support for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation. As gene therapy is still an emerging/fast progressing field, passion for continuous learning and capability to work in a highly dynamic, fast pace, collaborative environment is key to the success of this role. Responsibilities Perform lab experiments with oversight/guidance. Oversee method transfer, qualification/validation, trending across analytical network. Act as analytical technical lead for one or more projects with guidance. Work closely with Analytical Development group to transfer/co-qualify new methods. Collaborate with contract testing labs to ensure successful completion of projects to the standards of AveXis. Assist with authoring experimental protocols/reports and regulatory submissions related to analytical. Participate in assay troubleshooting and projects to improve method performance across network. Support OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions. Assist with responses to agency questions related to analytical methods/specification. Manage the use and maintenance of scientific equipment and instrumentation, computer systems. Qualifications BS with 4+ years' biopharmaceutical experience; MS with 2+ years' biopharmaceutical experience; Ph.D. Strong critical thinking and problem-solving skills. Experience with method development, transfer, qualification and validation. Experience in gene/cell therapy field is a plus. Must possess knowledge of some of the following: general protein/nucleic acid chemistry/biochemistry, basic molecular biology, basic understanding of GMP requirement and regulations (FDA/EMA/ICH etc.), Chromatography (RP, SEC, IEX, HILIC etc.), ELISA, cell based bioassay (potency, infectious titer assay etc.), PCR (qPCR, ddPCR etc.), analytical ultracentrifugation, spectroscopy (UV, fluorescence, FTIR), mass spectrometry (esp. ICP-MS), particle analysis. An excellent and persuasive communicator. Energetic, flexible, collaborative and proactive. Strong communication, scientific writing and presentation skills. 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-MG1
Position Summary The Director of Nursing plans, organizes, develops, and directs the overall operation of the Nursing department to ensure the highest degree of quality patient care in accordance with all applicable laws, regulations, and Life Care standards. Education, Experience, and Licensure Requirements Must have a minimum of an ASN degree from accredited college or university Must be currently licensed/registered in applicable State. Must maintain an active Registered Nurse (RN) license in good standing throughout employment. Must have two (2) years supervisory experience in a post acute care or related setting Must have CPR certification upon hire or obtain during orientation. CPR certification must remain current during employment. Specific Job Requirements Participates in community health matters/projects as appropriate Liaisons with patients, families, support departments, etc. to adequately plan for patient needs Must be able to collect, analyze, and manage data Must have expert knowledge in field of practice Must possess the ability to make independent decisions when circumstances warrant such action Must be knowledgeable of practices and procedures as well as the laws, regulations, and guidelines governing functions in the post acute care facility Must have the ability to implement and interpret the programs, goals, objectives, policies, and procedures of the department Must perform proficiently in all competency areas including but not limited to: patient rights, and safety and sanitation Maintains professional working relationships with all associates, vendors, etc. Maintains confidentiality of all proprietary and/or confidential information Must understand and follow company policies including harassment and compliance procedures Displays integrity and professionalism by adhering to Life Care's Code of Conduct and completes mandatory Code of Conduct and other appropriate compliance training Essential Functions Must be able to plan, develop, organize, implement, evaluate, establish benchmarks, and direct staff Must be able to recruit, select, hire, train, evaluate, counsel, and supervise nursing staff Must be able to assign appropriate level of CNAs and LPNs per shift Must be able to effectively manage department budget Must be able to direct care provided by nursing staff Must be able to provide direct nursing care as necessary Must be able to perform functions of a staff nurse as required Must be able to effectively manage and operate within budget Must exhibit excellent customer service and a positive attitude towards patients Must be able to assist in the evacuation of patients Must demonstrate dependable, regular attendance Must be able to concentrate and use reasoning skills and good judgment Must be able to communicate and function productively on an interdisciplinary team Must be able to sit, stand, bend, lift, push, pull, stoop, walk, reach, and move intermittently during working hours Must be able to read, write, speak, and understand the English language An Equal Opportunity Employer
Mar 31, 2020
Full time
Position Summary The Director of Nursing plans, organizes, develops, and directs the overall operation of the Nursing department to ensure the highest degree of quality patient care in accordance with all applicable laws, regulations, and Life Care standards. Education, Experience, and Licensure Requirements Must have a minimum of an ASN degree from accredited college or university Must be currently licensed/registered in applicable State. Must maintain an active Registered Nurse (RN) license in good standing throughout employment. Must have two (2) years supervisory experience in a post acute care or related setting Must have CPR certification upon hire or obtain during orientation. CPR certification must remain current during employment. Specific Job Requirements Participates in community health matters/projects as appropriate Liaisons with patients, families, support departments, etc. to adequately plan for patient needs Must be able to collect, analyze, and manage data Must have expert knowledge in field of practice Must possess the ability to make independent decisions when circumstances warrant such action Must be knowledgeable of practices and procedures as well as the laws, regulations, and guidelines governing functions in the post acute care facility Must have the ability to implement and interpret the programs, goals, objectives, policies, and procedures of the department Must perform proficiently in all competency areas including but not limited to: patient rights, and safety and sanitation Maintains professional working relationships with all associates, vendors, etc. Maintains confidentiality of all proprietary and/or confidential information Must understand and follow company policies including harassment and compliance procedures Displays integrity and professionalism by adhering to Life Care's Code of Conduct and completes mandatory Code of Conduct and other appropriate compliance training Essential Functions Must be able to plan, develop, organize, implement, evaluate, establish benchmarks, and direct staff Must be able to recruit, select, hire, train, evaluate, counsel, and supervise nursing staff Must be able to assign appropriate level of CNAs and LPNs per shift Must be able to effectively manage department budget Must be able to direct care provided by nursing staff Must be able to provide direct nursing care as necessary Must be able to perform functions of a staff nurse as required Must be able to effectively manage and operate within budget Must exhibit excellent customer service and a positive attitude towards patients Must be able to assist in the evacuation of patients Must demonstrate dependable, regular attendance Must be able to concentrate and use reasoning skills and good judgment Must be able to communicate and function productively on an interdisciplinary team Must be able to sit, stand, bend, lift, push, pull, stoop, walk, reach, and move intermittently during working hours Must be able to read, write, speak, and understand the English language An Equal Opportunity Employer
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 II 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, including organizing the warehouse in accordance with appropriate systems and processes. 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. Organize the warehouse and outside of the POD manufacturing area. Examples include KANBAN processes and waste streams. Qualifications H.S. Diploma required, B.S. degree is a plus. 1-3 years of pharmaceutical warehouse material handling experience is required. Prior experience with KANBAN system preferred. Forklift certification preferred. Experience driving trucks Must have valid driver's license with no violations within the last 3 years. 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-JB1
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 II 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, including organizing the warehouse in accordance with appropriate systems and processes. 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. Organize the warehouse and outside of the POD manufacturing area. Examples include KANBAN processes and waste streams. Qualifications H.S. Diploma required, B.S. degree is a plus. 1-3 years of pharmaceutical warehouse material handling experience is required. Prior experience with KANBAN system preferred. Forklift certification preferred. Experience driving trucks Must have valid driver's license with no violations within the last 3 years. 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-JB1
Job DescriptionColorado Escrow & Title is currently seeking a full-time experienced Escrow Processor to support the operations of the Longmont/Westminster Area. Essential Job Functions: Opening and Closing Office Answering Phones Mail Sorting Stocking Closing/Work Rooms General Office Duties Office Supply Ordering Respond to inquiries from customers, attorneys, agents and brokers. Provides support to the Escrow Department. Specific Knowledge & Skills: Knowledge of title software desired, Ramquest preferred. Understanding of basic computer programs (Microsoft Office) Familiar with the standard concepts, practices and procedures of the escrow and title process. Detailed oriented and professional; able to handle confidential information. Strong communication, both written and verbal. Financial and documentation skills. Must have excellent communication skills on all levels within and outside of the organization. Must take pride in quality work and excellent service. Must have a positive outlook. Must be a team player with a can-do attitude. Must be a professional with uncompromising ethics Highly dependable, puncutual, outgoing and friendly Colorado Escrow and Title is an Equal Opportunity Employer committed to workforce diversity. Qualified applicants will receive consideration without regard to age, race, color, religion, gender, sexual orientation, national origin, or their status as a protected veteran or an individual with disabilities. Local applicants encouraged to apply. Employment contingent upon successful completion of background investigation. Excellent benefits package including medical, dental, vision and 401(k). Job Type: Full-time
Mar 31, 2020
Full time
Job DescriptionColorado Escrow & Title is currently seeking a full-time experienced Escrow Processor to support the operations of the Longmont/Westminster Area. Essential Job Functions: Opening and Closing Office Answering Phones Mail Sorting Stocking Closing/Work Rooms General Office Duties Office Supply Ordering Respond to inquiries from customers, attorneys, agents and brokers. Provides support to the Escrow Department. Specific Knowledge & Skills: Knowledge of title software desired, Ramquest preferred. Understanding of basic computer programs (Microsoft Office) Familiar with the standard concepts, practices and procedures of the escrow and title process. Detailed oriented and professional; able to handle confidential information. Strong communication, both written and verbal. Financial and documentation skills. Must have excellent communication skills on all levels within and outside of the organization. Must take pride in quality work and excellent service. Must have a positive outlook. Must be a team player with a can-do attitude. Must be a professional with uncompromising ethics Highly dependable, puncutual, outgoing and friendly Colorado Escrow and Title is an Equal Opportunity Employer committed to workforce diversity. Qualified applicants will receive consideration without regard to age, race, color, religion, gender, sexual orientation, national origin, or their status as a protected veteran or an individual with disabilities. Local applicants encouraged to apply. Employment contingent upon successful completion of background investigation. Excellent benefits package including medical, dental, vision and 401(k). Job Type: 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 at our Durham site. The individual will collaborate closely with Analytical Development, Quality Control, and Project Management teams to qualify, validate, transfer and improve analytical methods. She or he will play an active role in establishing the site QC lab operations to support development and commercialization of new gene therapy medicines. The Sr QC Specialist is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification, validation, transfer, and improvement. The candidate should possess strong understanding of QC testing operations and provide expertise in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays. She or he is expected to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions. He/she will be able to work effectively within the group, within Quality, and across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/ communication with Quality management. Experience in cell culture and cell-based assays (e.g. virus infection assays and proliferation assays) is desired. Responsibilities Serve as SME in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays. Perform QC assays for in-process, release, or stability samples. Review and trend QC testing results. Lead assay troubleshooting, qualification, validation, and transfer. Manage the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems. Write and revise documents such as SOPs, method validation/transfer protocols, and technical reports. Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Identify and implement new technologies to improve the compliance and efficiency of QC operations. Represent QC to work 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 assigned. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 8 years of experience preferred with biological products in a GMP Quality Control laboratory. Excellent oral and written communication skills with strong technical writing experience required. Potential for up to 20% 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. #LI-MG1
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. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team at our Durham site. The individual will collaborate closely with Analytical Development, Quality Control, and Project Management teams to qualify, validate, transfer and improve analytical methods. She or he will play an active role in establishing the site QC lab operations to support development and commercialization of new gene therapy medicines. The Sr QC Specialist is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification, validation, transfer, and improvement. The candidate should possess strong understanding of QC testing operations and provide expertise in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays. She or he is expected to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions. He/she will be able to work effectively within the group, within Quality, and across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/ communication with Quality management. Experience in cell culture and cell-based assays (e.g. virus infection assays and proliferation assays) is desired. Responsibilities Serve as SME in several QC assays, such as cell-based potency, ELISA, qPCR, and separation assays. Perform QC assays for in-process, release, or stability samples. Review and trend QC testing results. Lead assay troubleshooting, qualification, validation, and transfer. Manage the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems. Write and revise documents such as SOPs, method validation/transfer protocols, and technical reports. Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Identify and implement new technologies to improve the compliance and efficiency of QC operations. Represent QC to work 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 assigned. Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 8 years of experience preferred with biological products in a GMP Quality Control laboratory. Excellent oral and written communication skills with strong technical writing experience required. Potential for up to 20% 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. #LI-MG1
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-MG1
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 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-MG1
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-MG1
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 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-MG1
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-MG1
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. 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-MG1
We are seeking a Family Law Attorney to become a part of our team! You will represent clients in legal proceedings, draw up legal documents and advise clients on legal transactions. Responsibilities: Represent clients in court or before government agencies Prepare and draft legal documents on behalf of clients Advise clients on business and legal transactions Negotiate settlements for legal disputes Comply with all legal standards and regulations Perform administrative and management functions related to the practice of law Qualifications: Previous experience in law Familiarity with various legal documents Strong analytical and problem-solving skills Ability to build rapport with clients Excellent written and verbal communication skills
Mar 30, 2020
Full time
We are seeking a Family Law Attorney to become a part of our team! You will represent clients in legal proceedings, draw up legal documents and advise clients on legal transactions. Responsibilities: Represent clients in court or before government agencies Prepare and draft legal documents on behalf of clients Advise clients on business and legal transactions Negotiate settlements for legal disputes Comply with all legal standards and regulations Perform administrative and management functions related to the practice of law Qualifications: Previous experience in law Familiarity with various legal documents Strong analytical and problem-solving skills Ability to build rapport with clients Excellent written and verbal communication skills
Description At Xilinx, we are leading the industry transformation to build an adaptable, intelligent world. ARE YOU bold, collaborative, and creative? At Xilinx, we hire and develop leaders and innovators who want to revolutionize the world of technology. We believe that by embracing diverse ideas, pushing boundaries, and working together as ONEXILINX, anything is possible. Our culture of innovation began with the invention of the Field Programmable Gate Array (FPGA), and with the 2018 introduction of our Adaptive Compute Acceleration Platform (ACAP), has made a quantum leap in capability, solidifying our role as the adaptable platform supplier of choice. From the start, we have always believed in providing inventors with products and platforms that are infinitely adaptable. From self-driving cars, to world-record genome processing, to AI and big data, to the world's first 5G networks, we empower the world's builders and visionaries whose ideas solve every day problems and enhance people's lives. If you are PASSIONATE, ADAPTABLE, and INNOVATIVE, Xilinx is the right place for you! At Xilinx we care deeply about creating meaningful development experiences while building a strong sense of belonging and connection. We foster an environment of empowered learning, wellness, community engagement, and recognition, so you can focus on work that matters - world class technology that improves the way we live and work. We are ONEXILINX. Special Requirements: Must have coursework, advance level coursework, or project background in the following: Automating software tasks through tools such as Jenkins. Commercial software quality assurance practices, methodologies and procedures. Software development using Object Oriented Programming techniques. Knowledge full software development lifecycle. Scripting using Python and or other scripting languages. Programming using Java (C++ is a plus). Developing in both Windows and Linux environments. Revision control tools such as Perforce. Full stack development including database, middleware and front-end, experience with NoSQL database such as elastic-search is a plus. Database design. Developing webpages using Angular Linux and windows shell scripting Docker/Kubernetes knowledge is a plus Education Requirements : Master's Degree or foreign equivalent in Computer Science or related field with 1-2 years of experience Bachelor's Degree with 2-4 years of relevant working experience. #LI-DG
Mar 30, 2020
Full time
Description At Xilinx, we are leading the industry transformation to build an adaptable, intelligent world. ARE YOU bold, collaborative, and creative? At Xilinx, we hire and develop leaders and innovators who want to revolutionize the world of technology. We believe that by embracing diverse ideas, pushing boundaries, and working together as ONEXILINX, anything is possible. Our culture of innovation began with the invention of the Field Programmable Gate Array (FPGA), and with the 2018 introduction of our Adaptive Compute Acceleration Platform (ACAP), has made a quantum leap in capability, solidifying our role as the adaptable platform supplier of choice. From the start, we have always believed in providing inventors with products and platforms that are infinitely adaptable. From self-driving cars, to world-record genome processing, to AI and big data, to the world's first 5G networks, we empower the world's builders and visionaries whose ideas solve every day problems and enhance people's lives. If you are PASSIONATE, ADAPTABLE, and INNOVATIVE, Xilinx is the right place for you! At Xilinx we care deeply about creating meaningful development experiences while building a strong sense of belonging and connection. We foster an environment of empowered learning, wellness, community engagement, and recognition, so you can focus on work that matters - world class technology that improves the way we live and work. We are ONEXILINX. Special Requirements: Must have coursework, advance level coursework, or project background in the following: Automating software tasks through tools such as Jenkins. Commercial software quality assurance practices, methodologies and procedures. Software development using Object Oriented Programming techniques. Knowledge full software development lifecycle. Scripting using Python and or other scripting languages. Programming using Java (C++ is a plus). Developing in both Windows and Linux environments. Revision control tools such as Perforce. Full stack development including database, middleware and front-end, experience with NoSQL database such as elastic-search is a plus. Database design. Developing webpages using Angular Linux and windows shell scripting Docker/Kubernetes knowledge is a plus Education Requirements : Master's Degree or foreign equivalent in Computer Science or related field with 1-2 years of experience Bachelor's Degree with 2-4 years of relevant working experience. #LI-DG
Welcome to Centura Health Welcome to Centura Health - the largest health ecosystem in Colorado and Kansas. Welcome to living your mission among thousands of people on fire to live theirs too. Welcome to options and possibility where you can chart the direction and flow of your career. Welcome to the freedom to believe in what you believe, and welcome to a family guided by shared values and a commitment to extending the healing ministry of Christ. Welcome to extremely important industry challenges and opportunities to solve complex problems. Welcome to highly intelligent teams and overflowing community. And welcome to wholeness of mind, body and spirit. Welcome to Centura Health. You have a purpose, unique talents and NOW is the time to embrace it, live it and put it to work. At Centura Health, we value incredible people with incredible skills - but your commitment to a greater cause is something we value even more. This is the heartbeat of our organization and your time will be spent in a supportive, team environment with resources to help you flourish and leaders who care about your success. Flourishing Begins Here As a physician-facing organization, Centura Health Physician Group (CHPG) is passionate about high-value, top quality care made accessible in every community we serve. Our resources include supply chain expertise, technology implementation trainers, contracting experts, centralized credentialing, financial reporting/modeling and communication - so providers can spend their time doing what matters most - caring for patients and serving their communities. Provide services at or above the customary practice standards in the Community, and within the qualifications and experience of Physician and adhere to the standards and principles of medical ethics of the American Medical Association, and all recognized associations or accrediting boards concerned with Physician's area of medical specialty. Call shared between providers Full-time (in clinic 4.5 days per week) What You Bring/Job Requirements In addition to bringing your whole self to the workplace each day, qualified candidates will need the following: Must have successfully completed a residency or fellowship commensurate with area of specialty. Obtain and maintain an unrestricted Drug Enforcement Agency ( DEA ) registration; Be board certified or eligible in the appropriate specialty, by a board acceptable to Hospital; Obtain Medical Staff Privileges within the Centura Health system, at sponsoring institution Doctorate or DO required MD - Obtain and maintain an unrestricted license to practice medicine in Colorado Physical Requirements - Medium Work - (Exert up to 50lbs force occasionally, and/or up to 20lbs frequently, and/or up to 10lbs constantly) Your Connected Community When people and places align, incredible things happen. Just like the 21,000+ amazing associates who work here, every community within Centura Health's connected ecosystem has its own unique history, story and personality. At Longmont United Hospital (LUH), we treat the entire patient to leverage the powerful the connection of body, mind, and spirit in the healing process. As a Planetree Designated® Hospital, staff members adhere to the highest possible standards and Healthgrades ranks us as one of the Top Hospitals in the Nation for Patient Experience. Here, your time at work will be spent with a supportive team of staff and leaders that value self-care, flexibility and development opportunities through cross-training and continuing education. Longmont, CO, is home to 2,000+ acres of parks, three public golf courses and numerous trails to hike, bike, walk or run. Located less than an hour away from the Rocky Mountain National Park (ranked the 4th most visited national park in the country in 2017 by the Denver Business Journal), you'll have easy access to the very best Colorado has to offer.
Mar 30, 2020
Full time
Welcome to Centura Health Welcome to Centura Health - the largest health ecosystem in Colorado and Kansas. Welcome to living your mission among thousands of people on fire to live theirs too. Welcome to options and possibility where you can chart the direction and flow of your career. Welcome to the freedom to believe in what you believe, and welcome to a family guided by shared values and a commitment to extending the healing ministry of Christ. Welcome to extremely important industry challenges and opportunities to solve complex problems. Welcome to highly intelligent teams and overflowing community. And welcome to wholeness of mind, body and spirit. Welcome to Centura Health. You have a purpose, unique talents and NOW is the time to embrace it, live it and put it to work. At Centura Health, we value incredible people with incredible skills - but your commitment to a greater cause is something we value even more. This is the heartbeat of our organization and your time will be spent in a supportive, team environment with resources to help you flourish and leaders who care about your success. Flourishing Begins Here As a physician-facing organization, Centura Health Physician Group (CHPG) is passionate about high-value, top quality care made accessible in every community we serve. Our resources include supply chain expertise, technology implementation trainers, contracting experts, centralized credentialing, financial reporting/modeling and communication - so providers can spend their time doing what matters most - caring for patients and serving their communities. Provide services at or above the customary practice standards in the Community, and within the qualifications and experience of Physician and adhere to the standards and principles of medical ethics of the American Medical Association, and all recognized associations or accrediting boards concerned with Physician's area of medical specialty. Call shared between providers Full-time (in clinic 4.5 days per week) What You Bring/Job Requirements In addition to bringing your whole self to the workplace each day, qualified candidates will need the following: Must have successfully completed a residency or fellowship commensurate with area of specialty. Obtain and maintain an unrestricted Drug Enforcement Agency ( DEA ) registration; Be board certified or eligible in the appropriate specialty, by a board acceptable to Hospital; Obtain Medical Staff Privileges within the Centura Health system, at sponsoring institution Doctorate or DO required MD - Obtain and maintain an unrestricted license to practice medicine in Colorado Physical Requirements - Medium Work - (Exert up to 50lbs force occasionally, and/or up to 20lbs frequently, and/or up to 10lbs constantly) Your Connected Community When people and places align, incredible things happen. Just like the 21,000+ amazing associates who work here, every community within Centura Health's connected ecosystem has its own unique history, story and personality. At Longmont United Hospital (LUH), we treat the entire patient to leverage the powerful the connection of body, mind, and spirit in the healing process. As a Planetree Designated® Hospital, staff members adhere to the highest possible standards and Healthgrades ranks us as one of the Top Hospitals in the Nation for Patient Experience. Here, your time at work will be spent with a supportive team of staff and leaders that value self-care, flexibility and development opportunities through cross-training and continuing education. Longmont, CO, is home to 2,000+ acres of parks, three public golf courses and numerous trails to hike, bike, walk or run. Located less than an hour away from the Rocky Mountain National Park (ranked the 4th most visited national park in the country in 2017 by the Denver Business Journal), you'll have easy access to the very best Colorado has to offer.
Welcome to Centura Health Welcome to Centura Health - the largest health ecosystem in Colorado and Kansas. Welcome to living your mission among thousands of people on fire to live theirs too. Welcome to options and possibility where you can chart the direction and flow of your career. Welcome to the freedom to believe in what you believe, and welcome to a family guided by shared values and a commitment to extending the healing ministry of Christ. Welcome to extremely important industry challenges and opportunities to solve complex problems. Welcome to highly intelligent teams and overflowing community. And welcome to wholeness of mind, body and spirit. Welcome to Centura Health. You have a purpose, unique talents and NOW is the time to embrace it, live it and put it to work. At Centura Health, we value incredible people with incredible skills - but your commitment to a greater cause is something we value even more. This is the heartbeat of our organization and your time will be spent in a supportive, team environment with resources to help you flourish and leaders who care about your success. Flourishing Begins Here As a physician-facing organization, Centura Health Physician Group (CHPG) is passionate about high-value, top quality care made accessible in every community we serve. Our resources include supply chain expertise, technology implementation trainers, contracting experts, centralized credentialing, financial reporting/modeling and communication - so providers can spend their time doing what matters most - caring for patients and serving their communities. Provide services at or above the customary practice standards in the Community, and within the qualifications and experience of Physician and adhere to the standards and principles of medical ethics of the American Medical Association, and all recognized associations or accrediting boards concerned with Physician's area of medical specialty. Call shared between providers Full-time (in clinic 4.5 days per week) What You Bring/Job Requirements In addition to bringing your whole self to the workplace each day, qualified candidates will need the following: Must have successfully completed a residency or fellowship commensurate with area of specialty. Obtain and maintain an unrestricted Drug Enforcement Agency ( DEA ) registration; Be board certified or eligible in the appropriate specialty, by a board acceptable to Hospital; Obtain Medical Staff Privileges within the Centura Health system, at sponsoring institution Doctorate or DO required MD - Obtain and maintain an unrestricted license to practice medicine in Colorado Physical Requirements - Medium Work - (Exert up to 50lbs force occasionally, and/or up to 20lbs frequently, and/or up to 10lbs constantly) Your Connected Community When people and places align, incredible things happen. Just like the 21,000+ amazing associates who work here, every community within Centura Health's connected ecosystem has its own unique history, story and personality. At Longmont United Hospital (LUH), we treat the entire patient to leverage the powerful the connection of body, mind, and spirit in the healing process. As a Planetree Designated® Hospital, staff members adhere to the highest possible standards and Healthgrades ranks us as one of the Top Hospitals in the Nation for Patient Experience. Here, your time at work will be spent with a supportive team of staff and leaders that value self-care, flexibility and development opportunities through cross-training and continuing education. Longmont, CO, is home to 2,000+ acres of parks, three public golf courses and numerous trails to hike, bike, walk or run. Located less than an hour away from the Rocky Mountain National Park (ranked the 4th most visited national park in the country in 2017 by the Denver Business Journal), you'll have easy access to the very best Colorado has to offer.
Mar 30, 2020
Full time
Welcome to Centura Health Welcome to Centura Health - the largest health ecosystem in Colorado and Kansas. Welcome to living your mission among thousands of people on fire to live theirs too. Welcome to options and possibility where you can chart the direction and flow of your career. Welcome to the freedom to believe in what you believe, and welcome to a family guided by shared values and a commitment to extending the healing ministry of Christ. Welcome to extremely important industry challenges and opportunities to solve complex problems. Welcome to highly intelligent teams and overflowing community. And welcome to wholeness of mind, body and spirit. Welcome to Centura Health. You have a purpose, unique talents and NOW is the time to embrace it, live it and put it to work. At Centura Health, we value incredible people with incredible skills - but your commitment to a greater cause is something we value even more. This is the heartbeat of our organization and your time will be spent in a supportive, team environment with resources to help you flourish and leaders who care about your success. Flourishing Begins Here As a physician-facing organization, Centura Health Physician Group (CHPG) is passionate about high-value, top quality care made accessible in every community we serve. Our resources include supply chain expertise, technology implementation trainers, contracting experts, centralized credentialing, financial reporting/modeling and communication - so providers can spend their time doing what matters most - caring for patients and serving their communities. Provide services at or above the customary practice standards in the Community, and within the qualifications and experience of Physician and adhere to the standards and principles of medical ethics of the American Medical Association, and all recognized associations or accrediting boards concerned with Physician's area of medical specialty. Call shared between providers Full-time (in clinic 4.5 days per week) What You Bring/Job Requirements In addition to bringing your whole self to the workplace each day, qualified candidates will need the following: Must have successfully completed a residency or fellowship commensurate with area of specialty. Obtain and maintain an unrestricted Drug Enforcement Agency ( DEA ) registration; Be board certified or eligible in the appropriate specialty, by a board acceptable to Hospital; Obtain Medical Staff Privileges within the Centura Health system, at sponsoring institution Doctorate or DO required MD - Obtain and maintain an unrestricted license to practice medicine in Colorado Physical Requirements - Medium Work - (Exert up to 50lbs force occasionally, and/or up to 20lbs frequently, and/or up to 10lbs constantly) Your Connected Community When people and places align, incredible things happen. Just like the 21,000+ amazing associates who work here, every community within Centura Health's connected ecosystem has its own unique history, story and personality. At Longmont United Hospital (LUH), we treat the entire patient to leverage the powerful the connection of body, mind, and spirit in the healing process. As a Planetree Designated® Hospital, staff members adhere to the highest possible standards and Healthgrades ranks us as one of the Top Hospitals in the Nation for Patient Experience. Here, your time at work will be spent with a supportive team of staff and leaders that value self-care, flexibility and development opportunities through cross-training and continuing education. Longmont, CO, is home to 2,000+ acres of parks, three public golf courses and numerous trails to hike, bike, walk or run. Located less than an hour away from the Rocky Mountain National Park (ranked the 4th most visited national park in the country in 2017 by the Denver Business Journal), you'll have easy access to the very best Colorado has to offer.
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 Engineer, Manufacturing Execution Systems (MES) is responsible for assisting with the global design, leading build and startup of the manufacturing execution systems for the Longmont site. The candidate will work with and have a dotted line responsibility to the AveXis Global MES Lead throughout the project, working across multiple AveXis sites to ensure a standardized implementation with other site MES engineers. After implementation, the candidate will support MES at the site level and wholly integrate into the site-based automation organization. The primary focus includes Emerson Syncade MES, including electronic logbooks, recipe management, materials management, sample management, workflow, user interfaces, instrument integration, etc. Travel to other sites is expected. Responsibilities Assist in the global system design, configuration, and lead the local site installation of MES software and associated hardware; including interacting with other teams as necessary. Participate on MES aspects of projects including expanding and harmonizing manufacturing system capabilities at the Longmont facility and across the company. Assist in developing and executing global MES design and deployment strategy for global AveXis gene therapy production. Prepare scopes of work and manage MES contractors as required to complete work on budget within project timelines. Develop project objectives working with user requirements and business plans. Provide technical direction to experienced engineers to achieve common outcomes across sites. Ensure data integrity of various shop floor electronic systems utilizing MES where appropriate. Support product platform through recipe/workflow design and implementation. Collaborate with internal business partners on priorities, timelines and transparent sharing of information. Develop specifications documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Author and maintain global 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 and adjust standards as necessary. Create and update procedures to drive project execution and operational efficiency/effectiveness/compliance. Deploy, maintain, and upgrade MES applications. Analyze and interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediations. Provide feedback to Global MES Lead on site issues. Maintain lifecycle site automation systems via change control. Assist in 24/7 on-call support for MES. Other related duties as assigned. Qualifications B.S. degree in Engineering, Computer Science, or related technical field. A minimum of 10 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 MES systems (Emerson Syncade). Experience in system level validation testing. Proven experience applying S88 and S95 in an electronic environment, including physical and procedural model. Solid understanding of electronic batch records, materials management, electronic logbooks, sample plans, workflow, and other MES related concepts. Working knowledge of network design and implementation, experience with troubleshooting and start-up of systems, and familiarity with networked instrumentation. Knowledge of industrial communication protocols such as OPC, Ethernet IP, etc. 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 processes and end products. Excellent oral and written communication skills. Experience managing 3rd 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. 20% travel during project stage. 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-JB1
Mar 28, 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 Engineer, Manufacturing Execution Systems (MES) is responsible for assisting with the global design, leading build and startup of the manufacturing execution systems for the Longmont site. The candidate will work with and have a dotted line responsibility to the AveXis Global MES Lead throughout the project, working across multiple AveXis sites to ensure a standardized implementation with other site MES engineers. After implementation, the candidate will support MES at the site level and wholly integrate into the site-based automation organization. The primary focus includes Emerson Syncade MES, including electronic logbooks, recipe management, materials management, sample management, workflow, user interfaces, instrument integration, etc. Travel to other sites is expected. Responsibilities Assist in the global system design, configuration, and lead the local site installation of MES software and associated hardware; including interacting with other teams as necessary. Participate on MES aspects of projects including expanding and harmonizing manufacturing system capabilities at the Longmont facility and across the company. Assist in developing and executing global MES design and deployment strategy for global AveXis gene therapy production. Prepare scopes of work and manage MES contractors as required to complete work on budget within project timelines. Develop project objectives working with user requirements and business plans. Provide technical direction to experienced engineers to achieve common outcomes across sites. Ensure data integrity of various shop floor electronic systems utilizing MES where appropriate. Support product platform through recipe/workflow design and implementation. Collaborate with internal business partners on priorities, timelines and transparent sharing of information. Develop specifications documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Author and maintain global 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 and adjust standards as necessary. Create and update procedures to drive project execution and operational efficiency/effectiveness/compliance. Deploy, maintain, and upgrade MES applications. Analyze and interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediations. Provide feedback to Global MES Lead on site issues. Maintain lifecycle site automation systems via change control. Assist in 24/7 on-call support for MES. Other related duties as assigned. Qualifications B.S. degree in Engineering, Computer Science, or related technical field. A minimum of 10 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 MES systems (Emerson Syncade). Experience in system level validation testing. Proven experience applying S88 and S95 in an electronic environment, including physical and procedural model. Solid understanding of electronic batch records, materials management, electronic logbooks, sample plans, workflow, and other MES related concepts. Working knowledge of network design and implementation, experience with troubleshooting and start-up of systems, and familiarity with networked instrumentation. Knowledge of industrial communication protocols such as OPC, Ethernet IP, etc. 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 processes and end products. Excellent oral and written communication skills. Experience managing 3rd 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. 20% travel during project stage. 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-JB1
ind1234 We are seeking a Service Technician to help us keep our property in great condition. Ideal candidates enjoy working with their hands, are mechanically inclined, and have excellent customer service skills. Where is the job located? Cloverbasin Apartments (Longmont, CO) Why work for Mission Rock? Mission Rock Residential is a fast-growing property management company looking for fantastic, customer service driven team members. With growth comes advancement opportunities! Great benefits! Mission Rock Residential offers excellent medical, dental and vision insurance to include a Flexible Spending Account and Health Savings Account. We provide company paid life insurance along with paid short and long-term disability insurance, 11 paid holidays, vacation, sick time, and a 401k program with match. You are eligible to receive a discount on Verizon phone service and accessories (even if you are already on a Verizon plan). You may also be eligible to receive a 30% discount on rent if you live at the property that you work or a 20% discount if you choose to live at a sister property that we manage. These discounts do not apply to all of our locations. The Job: Our Maintenance Technicians must be willing and able to learn quickly in a fast-paced, team environment. Some days are pressure filled and you'll need to remain flexible, resourceful, and efficient. Service Technicians may work with any of the following: HVAC Electrical Plumbing Carpentry Drywall Painting Appliances Exterior structures Swimming pools The Details: Our Service Technicians should have: Basic tools of the trade Be willing and able to work on-call Additional Information: The work schedule is Monday- Friday 9AM - 6PM *** Employment with Mission Rock is contingent upon the successful completion of a drug test and background check ***
Mar 28, 2020
Full time
ind1234 We are seeking a Service Technician to help us keep our property in great condition. Ideal candidates enjoy working with their hands, are mechanically inclined, and have excellent customer service skills. Where is the job located? Cloverbasin Apartments (Longmont, CO) Why work for Mission Rock? Mission Rock Residential is a fast-growing property management company looking for fantastic, customer service driven team members. With growth comes advancement opportunities! Great benefits! Mission Rock Residential offers excellent medical, dental and vision insurance to include a Flexible Spending Account and Health Savings Account. We provide company paid life insurance along with paid short and long-term disability insurance, 11 paid holidays, vacation, sick time, and a 401k program with match. You are eligible to receive a discount on Verizon phone service and accessories (even if you are already on a Verizon plan). You may also be eligible to receive a 30% discount on rent if you live at the property that you work or a 20% discount if you choose to live at a sister property that we manage. These discounts do not apply to all of our locations. The Job: Our Maintenance Technicians must be willing and able to learn quickly in a fast-paced, team environment. Some days are pressure filled and you'll need to remain flexible, resourceful, and efficient. Service Technicians may work with any of the following: HVAC Electrical Plumbing Carpentry Drywall Painting Appliances Exterior structures Swimming pools The Details: Our Service Technicians should have: Basic tools of the trade Be willing and able to work on-call Additional Information: The work schedule is Monday- Friday 9AM - 6PM *** Employment with Mission Rock is contingent upon the successful completion of a drug test and background check ***
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 Stability Coordinator will coordinate all work processes associated with the Product Stability Programs at AveXis Inc including organizing the Stability Study Design and ensuring test scheduling is executed in-house or at 3 rd party contract laboratories according to the respective stability protocols. The QC Stability Coordinator may act as a delegate for the Manager during regulatory inspections and be a document author for studies and procedures in support of the Product Stability and Sample Management Programs. Key accountabilities include, but are not limited to program management, data organization, technical writing, metrics, and investigations. A potential candidate will possess a strong understanding of Stability Testing requirements per ICH guidelines and FDA/EMEA regulations and ensure adherence to all GMP requirements. This position will also support the QC Department for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. Responsibilities Coordinates work processes associated with the AveXis Stability programs. Develops the Stability Study Design and ensures scheduling and testing of stability lots. Manages all stability studies through execution of the following: Authors protocols and reports; Data entry and review; Provides Quality representation on Product Working Teams for change controls, deviationsand Conducts Data analysis and authors trending reports. Supports subject matter expert for applicable studies during regulatory inspections. Serves as document author for procedures and work instructions in support of the Stability and Sample Management programs. Generates process related metrics, monitoring for efficiency. Generates metrics for stability and sample management programs. Provides stability data for regulatory filings. Provides stability summaries for annual product review. Authors Change Controls and assesses stability impact on proposed changes. Qualifications Bachelor's Degree in Chemistry, Biology or related sciences Minimum of 5 years of relevant experience in a pharmaceutical testing laboratory Experience and understanding of ICH stability guidelines. Prior experience with QC Stability and Sample Management and LIMS Expertise in use of Excel or comparable software solutions for management and analysis of data Strong problem-solving abilities Ability to work independently and effectively Ability to prioritize and deliver on tight timelines Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building Good critical thinking, deductive reasoning, and decision-making skills Ability to work effectively within the site and across 3rd party testing laboratories. Proven effective communication skills 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 27, 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 Stability Coordinator will coordinate all work processes associated with the Product Stability Programs at AveXis Inc including organizing the Stability Study Design and ensuring test scheduling is executed in-house or at 3 rd party contract laboratories according to the respective stability protocols. The QC Stability Coordinator may act as a delegate for the Manager during regulatory inspections and be a document author for studies and procedures in support of the Product Stability and Sample Management Programs. Key accountabilities include, but are not limited to program management, data organization, technical writing, metrics, and investigations. A potential candidate will possess a strong understanding of Stability Testing requirements per ICH guidelines and FDA/EMEA regulations and ensure adherence to all GMP requirements. This position will also support the QC Department for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. Responsibilities Coordinates work processes associated with the AveXis Stability programs. Develops the Stability Study Design and ensures scheduling and testing of stability lots. Manages all stability studies through execution of the following: Authors protocols and reports; Data entry and review; Provides Quality representation on Product Working Teams for change controls, deviationsand Conducts Data analysis and authors trending reports. Supports subject matter expert for applicable studies during regulatory inspections. Serves as document author for procedures and work instructions in support of the Stability and Sample Management programs. Generates process related metrics, monitoring for efficiency. Generates metrics for stability and sample management programs. Provides stability data for regulatory filings. Provides stability summaries for annual product review. Authors Change Controls and assesses stability impact on proposed changes. Qualifications Bachelor's Degree in Chemistry, Biology or related sciences Minimum of 5 years of relevant experience in a pharmaceutical testing laboratory Experience and understanding of ICH stability guidelines. Prior experience with QC Stability and Sample Management and LIMS Expertise in use of Excel or comparable software solutions for management and analysis of data Strong problem-solving abilities Ability to work independently and effectively Ability to prioritize and deliver on tight timelines Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building Good critical thinking, deductive reasoning, and decision-making skills Ability to work effectively within the site and across 3rd party testing laboratories. Proven effective communication skills 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.
Job Description:Whats the difference between a job and a meaningful, rewarding career? The people you serve. When you work at Atria, you have a front-row seat to the amazing life stories of the wisest people on earth. Whats more, you are part of an extraordinary company one thats investing in the future of senior living by investing in you. Dont just do a job. Be part of an extraordinary life.Atria Senior Living is a leading operator of independent living, assisted living, supportive living, and memory care communities in more than 225 locations in 27 states and seven Canadian provinces. We create vibrant communities where older adults can thrive and participate, know that their contributions are valued, and enjoy access to opportunities and support that help them continue making a difference in our world.Will support the Resident Services Director in carrying out the Resident Services Department functions. Assist in monitoring the medication management program and overseeing activity in the medication room. Will also assist in scheduling and supervising staff, including monitoring of overtime.-Schedule and supervise staff; available to cover staffing when needed.-Monitor, oversee and administer medications as allowed per state specific guidelines.-Provide activities of daily living assistance to residents.-Provide training and orientation to new staff members and ongoing training to current staff members.-Provide verbal encouragement and support to the staff.-Demonstrate flexibility by being open to changes and demonstrating a positive attitude.-Prioritize tasks to assure that customers changing needs are met in a timely manner.-Perform assessments and reassessments to determine resident needs and recommending appropriate service plans.-Does what is reasonably necessary to ensure customer satisfaction.-Look for ways to improve and promote quality and monitors the department for any unsafe issues; immediately report any concerning quality issues to the Resident Services ----Director or Executive Director.-Function as a role model for staff by being punctual, neat and clean in appearance and follows dress code.-May perform other duties as needed and/or assigned.
Mar 27, 2020
Full time
Job Description:Whats the difference between a job and a meaningful, rewarding career? The people you serve. When you work at Atria, you have a front-row seat to the amazing life stories of the wisest people on earth. Whats more, you are part of an extraordinary company one thats investing in the future of senior living by investing in you. Dont just do a job. Be part of an extraordinary life.Atria Senior Living is a leading operator of independent living, assisted living, supportive living, and memory care communities in more than 225 locations in 27 states and seven Canadian provinces. We create vibrant communities where older adults can thrive and participate, know that their contributions are valued, and enjoy access to opportunities and support that help them continue making a difference in our world.Will support the Resident Services Director in carrying out the Resident Services Department functions. Assist in monitoring the medication management program and overseeing activity in the medication room. Will also assist in scheduling and supervising staff, including monitoring of overtime.-Schedule and supervise staff; available to cover staffing when needed.-Monitor, oversee and administer medications as allowed per state specific guidelines.-Provide activities of daily living assistance to residents.-Provide training and orientation to new staff members and ongoing training to current staff members.-Provide verbal encouragement and support to the staff.-Demonstrate flexibility by being open to changes and demonstrating a positive attitude.-Prioritize tasks to assure that customers changing needs are met in a timely manner.-Perform assessments and reassessments to determine resident needs and recommending appropriate service plans.-Does what is reasonably necessary to ensure customer satisfaction.-Look for ways to improve and promote quality and monitors the department for any unsafe issues; immediately report any concerning quality issues to the Resident Services ----Director or Executive Director.-Function as a role model for staff by being punctual, neat and clean in appearance and follows dress code.-May perform other duties as needed and/or assigned.
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 Summer Intern will work at an AveXis site on various activities included, but not limited to, produce product, troubleshoot and/or validate equipment, help drive process improvements, help investigate deviations, provide market and other strategic analysis, and/or work with supply chain vendors. Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time. Responsibilities Project based scope could include manufacturing operations, documentation support, continuous improvement, and/or technology implementation. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering or life sciences. 3.0 GPA or better Excellent oral and written communication skills. Experience in leading projects. Additional Requirements: Must be able to routinely lift over 35 lbs. 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. 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 26, 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 Summer Intern will work at an AveXis site on various activities included, but not limited to, produce product, troubleshoot and/or validate equipment, help drive process improvements, help investigate deviations, provide market and other strategic analysis, and/or work with supply chain vendors. Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time. Responsibilities Project based scope could include manufacturing operations, documentation support, continuous improvement, and/or technology implementation. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering or life sciences. 3.0 GPA or better Excellent oral and written communication skills. Experience in leading projects. Additional Requirements: Must be able to routinely lift over 35 lbs. 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. 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.
