Batch Release Associate
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 Associate is responsible for the collection, review, and approval of upstream, downstream, and fill/finish manufacturing documentation in support of the manufacturing site. Will be responsible for making quality decisions, addressing and/or resolving problems based on written procedures and analysis. Will be responsible for communicating 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.
In addition to batch record review, job responsibilities include tasks associated with support of other quality systems included, but not limited to batch issuance, audit and Quality management review, change control, document management, and non-conformances. The Batch Release Associate will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFR's and cGMP's.
• Responsible for ensuring the conformance of the manufacturing and packaging processes to cGMP, company policies and procedures.
• Responsible for the release of intermediate and final product material both internally and externally for the site
• Review and approve master production records
• Partners with manufacturing to resolve issues related to batch documentation
• Provides support to Batch Issuance processes • Performs 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.
• Partners with cross-functional team to resolve documentation and batch related issues
• Create charts and provide tracking for key metric related batch record documentation.
• Provides cGMP observations to management; presents information to employees and management
• Minimum B.S. degree; life sciences background or emphasis preferred
• A minimum of 3-5 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.
Approximately 10% travel required
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.