Quality Control Analyst (Sun-Wed shift)

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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.

About the role

The successful candidate 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 position involves handling and testing samples in a BSL-2 environment and working in a GMP-compliant manner. The role 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-Wednesday shift. Work will also include coverage for holidays that fall during the shift schedule.

Responsibilities

• Perform potency assays for lot release and stability testing carried out Sunday-Wednesday.
• Support maintenance, 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.
• Maintain cell banks in cryogenic storage.
• Support method development, transfer, and qualification/validation activities associated with cell-based potency assays for AAV-based gene therapy products and other assays as required.
• 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 workflow for efficient management of team activities.
• Perform other related duties incidental to the work described.

Requirements

• B.S. degree in biology or biochemistry with coursework emphasizing molecular biology, cell biology, and/or virology.
• 2-5 years of relevant experience.
• Experience working with gene therapy products is highly desired.
• Strong understanding of method development and routine testing operations using capillary-based western blotting systems is desired.
• Experience working in a cGMP environment is desired.
• Strong understanding of cell culture methods, potency assays, agarose gel electrophoresis, Western blot, SDS-PAGE, and cell culture is necessary.
• Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary.
• Ability to operate as part of a team.
• Attention to detail is a must.
• Effective written and verbal communication skills.

Benefits

At Sarepta, we care deeply about all the people in our community and believe in supporting them in all aspects of their lives. We offer 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.

Pay

The targeted salary range for this position is $78,400 - $98,000 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.

Schedule

This position is fully onsite, comprising 4 - 10-hour days per week on a Sunday-Wednesday shift. Work will also include coverage for holidays that fall during the shift schedule.