Position located in Andover, MA

Responsibilities of the Sr. Analyst, Quality Control:

• 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.
• 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.
• This role will entail a certain percentage of lab work every week depending on other review priorities.

Requirements of the Sr. Analyst, Quality Control:

• BS or MS degree in molecular biology, cell biology or virology with at least 2-5 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.