Supervisor, Batch Release
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 clinical-stage, proprietary gene therapy candidate, 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 clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, 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.
The Batch Release Supervisor will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. The Batch Release Supervisor is responsible for making quality decisions and addressing or resolving issues based on experience, written procedures and analytical analysis, the oversight of the batch issuance and batch release processes, and supervision of all activities related to initiation, collection, review, and approval of media/buffer, upstream, downstream, and fill/finish manufacturing documentation in support of the manufacturing site.
- Supervision of the site Batch Release Team including time and attendance, personnel management and evaluation.
- Manage the batch review and lot disposition priorities and schedules to align with company timelines.
- Manage the Document Control processes for all records maintained and stored by the Batch Release team including MBRs, Forms, Logbooks, and executed protocols.
- Ensure compliance of the manufacturing and packaging process documentation to cGMP, company policies and procedures.
- Release of intermediate, final product material and clinical/ commercial packaging both internally and externally for the site, and the oversight thereof. This includes final documentation assembly, change control review, and the preparation of Certificates of Conformance.
- Certified Trainer for all Batch Disposition activities and roles.
- Ensure all area documentation remains in Compliance; author/update/approve SOPs, FORMs, etc. in documentation management system.
- Provide GDP expertise for the design of master production records.
- Provide oversight of the Batch Issuance processes.
- Perform mathematical calculations, including but not limited to: Adds and subtracts, divides units of measures using whole numbers, common fractions and decimals, and percentage, volume weights, and elapsed time.
- Partner with other functional business units - including manufacturing and validation - to resolve documentation and batch related issues.
- Create charts and provide tracking for key metric related batch record documentation.
- Provide cGMP observations to management; present information to employees and management.
- Communicate batch review status and issues effectively and promptly to all levels of the organization, as well as other departments such as Supply Chain and Manufacturing.
- Support of other quality systems to include, but not limited to, lot number issuance, batch disposition status changes, audit and quality management review, change control, document management, and non-conformances.
- Minimum B.S. degree; life sciences background or emphasis preferred.
- Must have comprehension of Batch Disposition processes.
- Previous experience with the supervision of teams and processes preferred.
- A minimum of 5 years of experience in pharmaceutical-based GMP manufacturing operations including direct experience in documentation review.
- Experience with viral gene therapies and/or orphan disease indications is a plus.
- Excellent oral and written communication skills.
- Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward; ideal applicant will be required to demonstrate high attention to detail, multi-tasking, and organization ability.
- Proficiency in and knowledge of MS Office, deviation and CAPA management software, and document management systems.
- Must have a strong knowledge and application of the CFR's and cGMP's.
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.