Gene Therapy Quality Control Lab Aid/ Gmp Contractor

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 working with internal Metrology, Facilities, and QC Review teams to align processes that will aid in improved review timelines. The individual will support reviewing data gathered from routine testing as well as from validations and qualifications. All aspects of this position would involve working in a GMP compliant manner.

• Review protocols, raw data packets, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, cell-based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally at Sarepta.

• Trend data for qualified materials, release products, and stability products.
• Assist with Freezer works (Sample Management inventory system), Sample submission and receiving paperwork, and support shipping of critical material (DOT/IATA training to be provided).
• Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
• Monitor, compile, and review analytical and QC data individually and with team members.
• Create and maintain clear, concise records and documentation.

• Perform other related duties incidental to the work described.

• Working experience in a cGMP environment is preferred.
• Associate or B.S degree in Biology, Chemistry, or related field with at least 1 year of relevant experience in an industry setting required.

• A basic understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays.
• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.
• Must have effective written and verbal communication skills.

• Operate as part of a team, assisting associates in providing a functional, safe working environment while maximizing laboratory efficiency.

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