AveXis Inc.

AveXis Inc. Durham, NC, USA
Apr 03, 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 Specialist, Quality Data Analytics is responsible for supporting each of the Global Quality functional areas with developing, tracking, and trending Key Performance Indicators (KPIs). This role serve as the "single source of truth" for metrics globally. This includes each all sites, Development QA, Global Quality Control, Compliance, Quality Systems, and Data Integrity. Responsibilities Assists with the establishment of cross-functional alignment on metrics serving as the "single source of truth" for quality metrics globally. This includes which metrics will be Helps identify what is to be collected, the definition for each metric, how often/when they will be reported, where they will be reported, and which function is responsible. Recommends appropriate mechanisms to collect and utilize metrics to inform decision making. Track non-Health Authority CAPAs to ensure on time closure.Assist in the collection and coordination of evaluations of emerging technologies. This includes assisting in the identifcation of owners in each quality function to evaluate emerging technologies, setting up a forum to evaluate these technologies, and aligning on a decision-making process for moving forward. Coordinate evaluation of emerging technologies. This includes identifying owners in each quality function to evaluate emerging technologies, setting up a forum to evaluate these technologies, and aligning on a decision-making process for moving forward. Support development of the Quality Plan, and management of work to ensure it is completed on time. Support tracking of hiring plans. This includes tracking hires to dates, progression of filling roles from creation of job description through onboarding, and working with HR and Finance to manage to approved plans. Other related duties as assigned. Qualifications B.S. degree in Engineering or the life sciences. 5 years of work experience in biopharmaceutical based GMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools. In-depth knowledge of FDA regulations and GMP systems and experience interacting with various regulatory agencies in a highly regulated or pharmaceutical / biotech facility. 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. Strong technical writing ability required. Proven ability to works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Travel as required to other internal sites, vendors, and CMOs as required (~10%). The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
AveXis Inc. Longmont, CO, USA
Apr 01, 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
AveXis Inc. San Diego, CA, USA
Apr 01, 2020
Full time
Overview We're Growing and looking for talented Research professionals! Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our proprietary gene therapy product, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis company , is a gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product, ZOLGENSMA®, is our proprietary gene therapy product for the treatment of spinal muscular atrophy, or SMA, the leading genetic cause of infant mortality. In addition to developing AVXS-101 to treat SMA, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsibilities Avexis is growing, so feel free to submit your resume! We are looking for individuals with expertise in vector biology, immunology, vivarium, assay development, cell and molecular biology, genetics or virology. We are looking for talented professionals to enhance and expand the AveXis platform and contribute to our strong pipeline of programs . Work will be executed with hands on work or leveraging internal capabilities across AveXis and Novartis, CRO work or academic collaboration. Tenacity, Integrity and Teamwork drive us towards our purpose and vision. Come join us and make a difference in the lives of patients suffering with life-threatening, rare genetic diseases. Qualifications The level of positions will be based on the final candidate's qualifications. 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-JH1
AveXis Inc. Durham, NC, USA
Apr 01, 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 Systems (QS) team at our site. The individual will collaborate closely with Manufacturing, Quality Assurance, Development, Quality Control, and Project Management teams to drive consistency in execution of non-conformances and change controls, drive continuous improvement initiatives and seek global alignments with other sites. She or he will play an active role in establishing the site QS processes to support development and commercialization of new gene therapy medicines. Responsible for driving consistency in execution of QS programs and participating in global initiatives to align QS processes at site level. This role will work independently on problem solving, investigations, change control and implementation of preventative and corrective actions, working effectively within the group, within Quality, and across sites. Responsibilities Serve as SME for Change Control, Non-Conformance and documentation programs. Provide guidance and training to site users in QS processes. Create monthly QS site metrics, monitor, review and trend QS programs. Lead Nonconformance and Change Control Review Board meetings. Ensure all deviations and change controls are appropriately documented and investigated following QS program procedures and guidelines. Review and/or author standard operating procedures and partner with operations on product related investigations and deviations. Review and approve Change Control and Nonconformances. 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 QS operations. Participate in Site inspection preparation and response process. Adhere to all GMP requirements. 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 in biopharmaceutical based GMP manufacturing operations. Strong understanding of QS programs such as change control and nonconformance. Understanding of FDA/EMEA regulations. Direct experience reviewing and/or authoring standard operating procedures. 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. #L1-GK1
AveXis Inc. Durham, NC, USA
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. This position is responsible for managing release activities for clinical QA activities in support of internal and external GMP activities for cell therapy products. Responsibilities Continually evaluate batch disposition priorities and recommend system improvements and maintain and enhance, in a phase-appropriate manner, the quality and compliance culture. Participates in audits, investigations, SOP preparation, CAPA's and other projects as appropriate. Support the management of batch release activities for clinical production including but not limited to review of batch records, analytical data with emphasis on the effect of safety and/or efficacy impact to the clinical study, certificates of analysis, evaluation of the IND and other documents. Provide quality assurance management, support, guidance and direction to internal manufacturing and external quality teams operating under phase appropriate cGMP regulations. Assists with the prioritization and coordination of batch release activities, to prevent supply disruption to the clinic. Supports identification of gaps/risks and opportunities for continuous improvement in the Quality System and their remediation and implementation respectively. Work across all functions (Supply Chain, Regulatory Affairs, Development, etc.) to support and ensure that all applicable internal Quality Standards/Policies and legislative requirements are maintained. Provide direction for deviations and CAPAs in support of batch release as well as understanding the specific impact on preclinical and clinical studies. Conduct follow-up / investigations when these can have an impact on release. Periodically conduct audits to ensure that systems are operated in accordance with established SOPs and GMPs. Manage Product Specification Files to support clinical release. For areas of responsibilities continuously follows new regulatory regulations and guidelines and discusses/proposes their implementation when deemed necessary. Support preparation for regulatory agency inspections and participate as a Subject Matter Expert during regulatory GMP inspections. Acts as delegate to QA Associate Director, Clinical Product Release as required. Other related duties as assigned. Qualifications B.S. or advanced degree in chemistry, microbiology or related science. 8 years of experience in the gene therapy / biopharmaceutical industry and 2 years direct experience managing preclinical and clinical quality release activities. Strong knowledge and application of the CFRs, and international regulations and have been involved in regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). Previous experience with batch release to market and/or clinic. Good knowledge of biologics cGMP manufacturing including ideally recombinant protein and cell therapy cGMP manufacturing. Proven management skills with ability to work with high performing teams, and lead others effectively. Experience with cGMP manufacturing of clinical trial material. Audit and investigation skills. Good verbal, written, and interpersonal communication skills. Proficiency in Microsoft Office applications. Ability to operate in a fast-paced, multi-disciplinary environment. > 20% travel. 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-GK1
AveXis Inc. Longmont, CO, USA
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 Production Control Specialist II is responsible for demonstrating a multi-disciplined competence of Production Support key deliverables - the initiation, management, and completion of change control records, nonconformance investigations, CAPA ownership, and manufacturing metrics collection and communication. Responsibilities Provide ownership and support across several disciplines in Production Support; Change Control, Investigations, and Metrics. Initiate, own, and drive complex change controls related to manufacturing operations -including multi-site and phased implementations. Effectively 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. Collection, maintenance, and reporting of Manufacturing metrics to the organization 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. Experience in 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 best practices regarding change control and change management, investigations, and CAPAs. Management of multiple projects and timelines concurrently. 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. Develop and communicate progress updates and presentations to all levels of the site organization, as required. 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
AveXis Inc. Durham, NC, USA
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 Senior Scientist is responsible for contributing to the development and improvement of the downstream manufacturing platform processes used to manufacture, as well as the data and reports to support approval of, AveXis gene therapy products. This individual will lead and support activity with internal and external organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. The Scientist will provide leadership and support for process, analytical, and characterization knowledge related to the production of AveXis gene therapy products, and the raw materials needed to make them. Responsibilities of primary importance are to ensure the execution of time-sensitive experiments, studies, and validation at external partners while capturing related data and knowledge, to advance the development of AveXis products from Research to Development, and on to GMP manufacturing. Complete requisite training on all applicable policies and procedures related to the job function. The successful candidate will take responsibility to ensure all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory approval of AveXis products. Responsibilities Provide scientific and technical input for process-related issues at internal Avexis sites, as well as with external partners. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Identifying and implementing potential process improvements in conjunction with manufacturing operations. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc. Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting. Participate in leading investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective. Participate in the collection and interpretation of data, and collaboration with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals. Qualifications Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, Master's degree or PhD preferred. Excellent oral and written communication skills. 6-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture. Previous experience with AAV manufacturing or Process Development is required Specific laboratory experience desired includes, but is not limited to: In depth knowledge of AKTA chromatography systems In depth knowledge of Chromatography, Depth Filtration, Tangential Flow Filtration, and Ultracentrifugation Familiarity with TFF scale up including flux, sheer, and TMP in hollowfiber and flat sheet membranes Familiarity with chromatography scale up Ability to effectively and efficiently analyze and interpret data to further progress development strategies. Working knowledge in DOE is a significant plus. Approximately 10% to 25% travel may be 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-JH1
AveXis Inc. Libertyville, IL, USA
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The HR Manager is a key individual contributor responsible for employee relations activities and is a business partner for our front-line leaders in a fast-paced manufacturing environment. Working in partnership with the site HR lead, this role focuses on proactively developing innovative HR solutions to drive issue resolution and a culture that attracts and retains an engaged workforce. This individual will work closely with the HR team both locally and remotely to define and accomplish HR goals that support business success. Responsibilities Partner with management, providing HR guidance and support in the areas of performance management and employee relations (e.g., coaching, counseling, career development, disciplinary actions) with guidance from the site HR lead. Develop strong, effective, working relationships across groups to lead and support managers and employees in the areas of retention, morale, productivity, policy interpretation and implementation, conflict resolution, and cultural integration. Manage and resolve complex employee relations issues. Conduct effective, thorough, and objective investigations. Assist managers and employees in understanding and applying HR and other tools, resources, and processes in order to maximize employee performance, achieve organizational effectiveness, and improve employee engagement. Engage in talent acquisition by actively participating in workforce planning and job description development; participate in recruiting efforts by offering coaching, behavioral interviewing guidance, and recommendations to ensure the best candidate is hired and retained. Proactively identify opportunities for initiatives and programs to enhance employee engagement and partner with supervisors, managers, and teams to execute HR strategies and activities for the site; work closely with HR team members to execute strategies that are focused on talent management, organizational effectiveness, and employee engagement. Answer employee questions about our HR programs, policies, and other people-related items, researching issues and responding with accuracy and a focus on the customer. Conduct exit interviews and provide data driven recommendations on employee retention. Manage and report department metrics; conduct research and analyze trends and metrics in partnership with the HR team and business to develop solutions, programs, and site policies and procedures. Own and execute on project deliverables, meet milestones and drive projects to completion. Maintain in-depth knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance. Qualifications Bachelor's degree required; Master's in Labor Relations, Business, Industrial Relations or similar discipline a plus. Minimum of 6 years of related Human Resources experience required, preferably in pharma, biopharma, or biotechnology. Experience working in a manufacturing, operations, or supply chain environment a plus. Ability to build strong relationships with peers and cross functionally with business partners. Demonstrated ability to leverage partner HR functions to deploy resources and programs that positively impact the business. Ability to communicate effectively with leaders and collaborate with staff at all levels and in a variety of situations with professionalism. Strong analytical and problem-solving skills. Ability to learn fast, know the business, handle ambiguity, and change course quickly when needed. Well organized with a disciplined approach to evaluating priorities in a changing environment. Demonstrated in-depth knowledge of employment/labor regulations. Ability to model and demonstrate work behaviors that are consistent with each of the company's core values: Tenacity, Teamwork, and Integrity. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. Durham, NC, USA
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 QC Microbiology Supervisor in our new gene therapy production center located in Durham, NC. You will work with the Quality Control team in supporting our efforts in this exciting new area of gene therapy. In this role you will be responsible for the day to day oversight of the QC Microbiology team. You will also be responsible for the environmental and utilities monitoring, raw material testing, and final product testing. Responsibilities Supervision of all QC Micro laboratory testing. Sustain environmental monitoring program for AveXis. Management and optimization of the Aseptic gowning training and qualification program. Management of QC Microbiology training program. Work with QC raw materials team to establish specifications and testing process of raw materials. SME on investigations of sterility failures and environmental excursions. Monitor and trend data Assemble reports on findings from environmental monitoring of Avexis's cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release. Develop, revise and review SOPs, qualification/validation protocols and reports. Conduct investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro procedures. Provide updates at daily and weekly meetings. 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. Other duties as assigned. NOTE: Shift to include weekends and second shift hours within a 24x7 manufacturing environmnet. Qualifications Bachelor's degree or advanced degree in Microbiology or related discipline. Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment. A minimum of 5 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 1 year experience supervising/managing/leading microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry. The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell/gene therapy product. Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes. The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift up to 25 lbs. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, cGMPs, microbiological method development and validation. Strong data integrity knowledge and practices. Identifying, writing, evaluating and closing OOS investigations. Strong knowledge of aseptic manufacturing and EM processes. Equipment and utility IQ/OQ/PQ/PV. Proficient in MS Word, Excel, Power Point and other applications. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. 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. #L1-GK1
AveXis Inc. Longmont, CO, USA
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
AveXis Inc. Libertyville, IL, USA
Mar 31, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Warehouse Associate is responsible for receiving, sampling, storing, issuing and shipping materials. This individual will work with the supply chain team to ensure inventory levels are accurate and materials are stored in the appropriate locations. This individual will support all manufacturing activities at the site. Responsibilities Receive all materials that come into the facility. Locate and store all inventory items in the ERP system and physically locate them. Work with Production and Labs for materials that are required and need to be issued out. Responsible for shipping all materials out of the facility. This includes hazmat shipments, export shipments and temperature sensitive shipments. Responsible to stay current on all training and shipping regulations. Complete inventory cycle counts to maintain current inventory accuracy. Qualifications H.S. Diploma required, B.S. degree is preferred. This is an entry level position, but 1+ years of pharmaceutical warehouse material handling experience is preferred. Forklift certification preferred. Strong communication and organizational skills, detail oriented. Must be physically able to lift and move materials (up to 50 lbs.) safely. Must work well in a team setting. Must maintain a professional work environment. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
AveXis Inc. Libertyville, IL, USA
Mar 30, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Director, Quality Systems is responsible for designing and implementing robust Quality Systems for our gene therapy manufacturing site in Libertyville, IL. This person will be responsible for the strategic site quality system design and work in collaboration with Manufacturing Operations to authorize written procedures including but not limited to monitor and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice. This position will develop quality related business systems such as deviation, CAPA, OOS, product complaints and facility wide GMP training and provide critical quality expertise to produce commercially approved Gene Therapy products. Responsibilities Develop and deliver a robust overall quality system, strategy, and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes. Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Hire and develop a high-performing quality team to ensure robust quality systems are implemented and sustained including: SOP/Document Management: Manage approval of all instruction sets, specifications, sampling instructions, test methods and other Quality control procedures directly related to operations and other cGMP activities. Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations. Lead site inspection preparation, management and response process. Provide quality input across the AveXis manufacturing network. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product. Experience with viral gene therapies and/or orphan disease indications is a plus. 10+ years of direct supervisory experience of technical professionals with demonstrated effectiveness to recruit and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). Excellent oral and written communication skills with strong technical writing experience. Experience leading both internal and external vendor audits, identifying findings, driving resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. Approximately 10% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
AveXis Inc. Longmont, CO, USA
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
AveXis Inc. Longmont, CO, USA
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
AveXis Inc. Durham, NC, USA
Mar 30, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Scientist is responsible for contributing to the development and improvement of the downstream manufacturing platform processes used to manufacture, as well as the data and reports to support approval of, AveXis gene therapy products. This individual will lead and support activity with internal and external organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. The Scientist will provide leadership and support for process, analytical, and characterization knowledge related to the production of AveXis gene therapy products, and the raw materials needed to make them. Responsibilities of primary importance are to ensure the execution of time-sensitive experiments, studies, and validation at external partners while capturing related data and knowledge, to advance the development of AveXis products from Research to Development, and on to GMP manufacturing. Complete requisite training on all applicable policies and procedures related to the job function. The successful candidate will take responsibility to ensure all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory approval of AveXis products. Responsibilities Provide scientific and technical input for process-related issues at internal Avexis sites, as well as with external partners. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Identifying and implementing potential process improvements in conjunction with manufacturing operations. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc. Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting. Participate in leading investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective. Participate in the collection and interpretation of data, and collaboration with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals. Qualifications Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, Master's degree or PhD preferred. Excellent oral and written communication skills. 6-10 years of experience in biopharmaceutical based process development or GMP manufacturing scientific support with direct downstream experience Proven expertise with a variety of TFF, chromatography, and other downstream unit operations and technologies Ability to effectively and efficiently analyze and interpret data to further progress development strategies Working knowledge in DOE is a significant plus Additional Requirements: Approximately 10% may be 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-JH1
AveXis Inc. San Diego, CA, USA
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 Associate Director is responsible for preclinical and clinical QA activities that drive the IND engine at AveXis, for novel viral gene therapies. This person will be responsible for decision-making regarding all quality assurance topics and for collaboration with core team members to ensure quality and compliance for the product candidate(s) managed. A successful candidate will provide critical strategic quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFRs and international regulations and have been involved in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international). This candidate may describe themselves as passionately devoted to their patients. And, if you are the kind of person who dares to dream of something more than traditional treatments and instead wants to be a critical part of making transformational therapies a reality for patients who need it the most, then this might be the right place for you. Responsibilities Provide leadership and quality expertise to project teams on the development and implementation of novel quality pathways for all aspects of the manufacturing process and method development including starting materials, plasmids, vectors and method qualification/validation for testing through the development product lifecycle (preclinical and clinical studies). Provide strategic quality leadership on the input into the IND of major investigational product and commercial submissions and response to HA queries, assuring that they are complete, scientifically accurate, of high quality and are presented in a way that facilitates both internal and agency review. Evaluate program(s) providing strategic quality decisions and documentation approvals as required. Evaluate and communicate risks to the development program(s) you manage to ensure successful launch of life changing products. Ensure filing and inspection readiness from an end-to-end product lens, and as needed, support both site readiness and any applicable interactions with regulatory agencies. Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies. Serve as the quality lead to support product risk assessments, supporting the identification of quality risks and appropriate mitigation plans to achieve compliant solutions. Ensure the product team's understanding of quality and compliance standards and market specific regulations for aligned programs, serving as the escalation lead on behalf of Quality to guide and manage challenges to achieve risk-based solutions as challenges occur. Identify and drive continuous improvement and standard practices for Quality to achieve both top performance and consistency, where appropriate, across our portfolio. Define the stage appropriate gates required for preclinical and clinical method development programs. Support the definition and requirements for development programs. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs, product specifications, analytical testing and release at CMOs and internal AveXis sites. Ensure all stability studies are designed and executed to enable IND and eventual commercialization. Qualifications Bachelors' and/or Masters/PhD' degree in scientific discipline with a technical understanding of biopharmaceutical production and/or understanding of cell or gene therapy and drug product development and manufacturing and testing. Minimum of 10-12 years of biologics or gene therapy industry experience in technical, quality, and/or regulatory role(s) supporting programs in pre-clinical and clinical phase programs, with at least one or more role (5+ years) in Quality (QA, QC). Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring IND/BLA sections of regulatory filings and partnering with operations on product related investigations and deviations. Strong project management skills and ability to communicate effectively across matrix functions at all levels of the organization, influencing areas not under direct control to achieve shared objectives while balancing speed, quality and risk. Proficiency in development and execution of strategic decisions, balancing multiple priorities in a fast-paced environment while promoting a culture of quality and continuous improvement. Approximately 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-GK1
AveXis Inc. Durham, NC, USA
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 Systems (QS) team at our site. The individual will collaborate closely with Manufacturing, Quality Assurance, Development, Quality Control, and Project Management teams to drive consistency in execution of non-conformances and change controls, drive continuous improvement initiatives and seek global alignments with other sites. She or he will play an active role in establishing the site QS processes to support development and commercialization of new gene therapy medicines. Responsible for driving consistency in execution of QS programs and participating in global initiatives to align QS processes at site level. This role will work independently on problem solving, investigations, change control and implementation of preventative and corrective actions, working effectively within the group, within Quality, and across sites. Responsibilities Serve as SME for Change Control, Non-Conformance and documentation programs. Provide guidance and training to site users in QS processes. Create monthly QS site metrics, monitor, review and trend QS programs. Lead Nonconformance and Change Control Review Board meetings. Ensure all deviations and change controls are appropriately documented and investigated following QS program procedures and guidelines. Review and/or author standard operating procedures and partner with operations on product related investigations and deviations. Review and approve Change Control and Nonconformances. 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 QS operations. Participate in Site inspection preparation and response process. Adhere to all GMP requirements. 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 in biopharmaceutical based GMP manufacturing operations. Strong understanding of QS programs such as change control and nonconformance. Understanding of FDA/EMEA regulations. Direct experience reviewing and/or authoring standard operating procedures. 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. #L1-GK1
AveXis Inc. San Diego, CA, USA
Mar 30, 2020
Full time
Overview We're Growing and looking for talented Research professionals! Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our proprietary gene therapy product, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis company , is a gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product, ZOLGENSMA®, is our proprietary gene therapy product for the treatment of spinal muscular atrophy, or SMA, the leading genetic cause of infant mortality. In addition to developing AVXS-101 to treat SMA, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsibilities Avexis is growing, so feel free to submit your resume! We are looking for individuals with expertise in vector biology, immunology, vivarium, assay development, cell and molecular biology, genetics or virology. We are looking for talented professionals to enhance and expand the AveXis platform and contribute to our strong pipeline of programs . Work will be executed with hands on work or leveraging internal capabilities across AveXis and Novartis, CRO work or academic collaboration. Tenacity, Integrity and Teamwork drive us towards our purpose and vision. Come join us and make a difference in the lives of patients suffering with life-threatening, rare genetic diseases. Qualifications The level of positions will be based on the final candidate's qualifications. 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-JH1
AveXis Inc. Libertyville, IL, USA
Mar 30, 2020
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The successful candidate will be responsible for the Quality oversight of manufacturing operations on the floor and working in collaboration with AveXis staff. Responsiblities include but are not limited to the following: review and approve written procedures, on the floor batch record documentation review, monitor and control the manufacturing environment, plant hygiene, process validation, people/process/waste flow patterns, aseptic certification, nonconformance review/disposition, and monitoring compliance with all requirements of good manufacturing practice. The Manufacturing Quality Associate is responsible for supporting the design and implementation of robust Quality Systems for a new viral gene manufacturing site and quality on the manufacturing floor. The Manufacturing Quality Associate will be responsible for quality related business systems such as non-conformance/CAPA, by contributing and reviewing for approval and assisting with the implementation and supporting on-going continuous improvements. The Manufacturing Associate will use risk based decision to address any issues on the Manufacturing floor and will serve as the quality point of contact for the operations. Will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a good knowledge of and application of the CFR's and cGMP's . Responsibilities Complete on the floor quality audits and sampling during the manufacturing processes; knowledge of AQLs and visual inspection preferred Good understanding of batch record execution, GMP and GDP. Knowledge of upstream and downstream processing necessary. Work effectively with operators on the floor and make on the spot, risk based decisions; escalate issues to management as necessary Assist in developing and delivering robust overall quality systems resulting ina fully compliant facility with respect to procedures and processes Contribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics; reporting to management all necessary information from plant floor Provide support on quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA's) and critical processing parameters (CPP's) Support and review of SOPs/Document Management: documentation management and SOPs all instruction sets, specifications, batch records etc. and other Quality procedures directly related to operations and other cGMP activities o On the floor Batch record review. Ability to review controlled documentation during processing for GMP and GDP Non-conformance/CAPA Management support and initial review of Non-conformances and CAPAs Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans and assist in determining a root cause o In process sampling/ AQL sampling Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product Qualifications Minimum B.S. degree in preferably microbiology, chemistry or biochemistry or 5 years applicable industry experience A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish Experience with viral gene therapies and/or orphan disease indications is a plus Knowledge of FDA regulations and experience in US and international regulatory agency inspections Direct experience reviewing standard operating procedures and partnering with operations on product related investigations and Non-conformances Excellent oral and written communication skills with strong technical writing experience required Experience with internal audits responsibilities and activities may change at any time with or without notice. Willing to work off-shift hours as directed. This position will be located out of our Chicago area office. Limited travel. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-TM1
AveXis Inc. Libertyville, IL, USA
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. Responsible for regulatory CMC activities and maintaining regulatory CMC applications. Responsible for executing the regulatory CMC strategy for submissions to the US- FDA, EMA, and other regulatory authorities as well as managing interactions with regulatory authorities on CMC issues. Work collaboratively with all AveXis functions to advance approved and development products globally. Responsibilities Implement regulatory CMC strategy for early and late stage clinical product candidates to attain rapid regulatory approvals. Lead and drive CMC content development for submission activities (planning, authoring, reviewing and coordination) for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications, BLAs, MAAs and global submissions. Serve as RA CMC liaison with various internal functions (e.g., Manufacturing, Quality, MS&T, R&D, etc.). Participate on multidisciplinary teams to prepare CMC updates for regulatory documents including IND CMC updates, Regulatory Authority meetings briefing documents, annual reports, etc. Support the overall development of a regulatory dossier for AveXis products globally. Respond to CMC queries to advance AveXis clinical programs and product approvals. Aid in establishing, managing, and maintaining a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices. Assure compliance with regulatory standards and guidance documents. Ensure that CMC-related changes are reported to authorities in accordance with regulatory requirements. Assist in developing risk assessments for global CMC regulatory issues. Help in building a world class Regulatory CMC function to meet AveXis growing pipline. Maintains and builds upon AveXis' excellent reputation with global regulatory authorities. May supervise employees as appropriate to meet business needs. Qualifications BS/MS degree in a scientific or related discipline. 5 to 8 years of drug or biologic regulatory experience, direct team management experience a plus. Experience and a proven track record of successes in biological drug submissions (e.g., IND, BLA, MAA, CTA), is preferred. Experience with biologics required with experience in cell/gene therapy drug development highly desirable. Knowledge of the drug development process and understanding of global regulatory requirements. Proven ability to work cross-functionally with QA, manufacturing and other business functions. Strong analytical skills, problem solving ability and presentation skills required. Flexibility and ability to prioritize and manage multiple tasks simultaneously. Effective oral and written communication Ability to understand cross functional challenges and develop a solution to meet project goals and timelines. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1