Senior Associate, Gene Therapy Quality Control

Sarepta Therapeutics
United States, Massachusetts, Andover
Mar 25, 2025
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role This individual will support quality control activities in the field of AAV therapeutic release and stability conducted both internally at Sarepta Andover facility and at contract vendors such as contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs). The work involves reviewing data gathered from routine testing as well as from validations and qualifications. The scope will also include generating certificates of analysis/testing (CoA/CoTs), standard operating procedures (SOPs), and oversight of CTLs. The individual will also assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner. The Opportunity to Make a Difference Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally at Sarepta. Act as company liaison with CMOs to coordinate in method development, method transfer, and release and stability testing across various CMO/CRO sites as needed. Monitor, compile, and review analytical and QC data individually and with team members. Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents. Create and maintain clear and concise records and documentation. Support the method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents and reference material. Trend data for qualified materials, release products, and stability products. Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites. Author and review test methods, development reports, study protocols, and validation reports. Perform other related duties incidental to the work described. More about You B.S. or M.S. degree in molecular biology, cell biology or virology with at least 5-8 years relevant experience. Working experience in a cGMP environment is preferred. A strong understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays. A familiarity with compendial (USP, ICH, EP) guidance is highly desired. Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary. Experience in developing, validating, and deploying molecular biology test methods is useful. Must have effective written and verbal communication skills. What Now? We're always looking for solution-oriented, critical thinkers. So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $92,000 - $115,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.