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Form of workThe Quality Control Analyst will work within the QC team, testing gene therapy products utilizing cell-based assays (Potency assay) in support of clinical and commercial lot release and stability activities. These assays are conducted in-house at the Sarepta facility in Andover, MA., with additional testing performed at contract testing laboratories (which may require periodic SME support). The successful candidate will have hands-on experience with cell-based in-vitro potency assays, SDS-PAGE, Automated Western blot assays, enzyme activity measurements, protein extraction, purification, and quantification methods. The required work involves handling and testing samples in a BSL-2 environment. All aspects of this position involve working in a GMP-compliant manner. The successful candidate will also assist in authoring and managing quality events (deviations, CAPAs, Change Controls etc.), as well as conducting data analysis and trending (for internal and external testing laboratories). Upon successful completion of training, this position will be fully onsite comprising 4 -10 hour days per week: Sunday to Wednesday shift. Work will also include coverage for holidays that fall during the shift schedule.
Primary Responsibilities Include:
- Support troubleshooting and optimization of cell culture and bioassays such as in-vitro potency.
- Prepare, qualify, and release standards for the in-vitro potency methods.
- Test new cell lines for use in new potency assays
- Maintaining cell banks on cryogenic storage
- Support method development, transfer and qualification/validation activities associated with the cell-based potency assays for AAV-based gene therapy products.
- Create and maintain clear and concise lab records and documentation.
- Support the authoring of test methods, development reports, study protocols, and validation reports.
- Support sample management: Inventory and tracking of incoming and outgoing samples.
- Collaborate with team leads and managers to optimize a smooth workflow for efficient management of team activities.
- Perform other related duties incidental to the work described.
Desired Education and Skills:
- B.S. degree in biology or biochemistry with course work emphasizing molecular biology, cell biology, and/or virology. 2-5 years of relevant experience is necessary. Experience working with gene therapy products is highly desired.
- A strong understanding of method development and routine testing operations using the Protein Simple Jess - Capillary electrophoresis western blotting system.
- Experience working in a cGMP environment is desired.
- A strong understanding of cell culture methods - Potency, Agarose gel electrophoresis, SDS-PAGE, and cell banking is necessary.
- Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary.
- Must be able to operate as a part of a team.
- Attention to details is a must.
- Effective written and verbal communication skills.
#LI-Onsite
This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $72,000 - $90,000 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.
