Quality Control Analyst (Sun-Wed shift)

Why Sarepta?

Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy (Duchenne) and building a robust portfolio across muscle, central nervous system, and cardiac diseases. In 2023, Sarepta launched its fourth therapy and the first-ever gene therapy to treat Duchenne. We seek individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

What Sarepta Offers

Sarepta is committed to supporting employees in all aspects of their lives, fostering a culture where people bring their whole selves to work. We offer a range of benefits and work-life resources, including:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of comprehensive benefits, visit our website.

About the Role

The successful candidate will work within the QC team, testing gene therapy products using cell-based assays (Potency assay) to support clinical and commercial lot release and stability activities. Testing is conducted in-house at the Sarepta facility in Andover, MA, with additional support provided to contract testing laboratories. The role involves handling samples in a BSL-2 environment and working in a GMP-compliant manner.

This position will be fully onsite, comprising 4 × 10-hour days per week on a Sunday–Wednesday shift, including coverage for holidays that fall during the shift schedule.

Responsibilities

• Perform potency assays for lot release and stability testing on a Sunday–Wednesday schedule.
• Support maintenance, troubleshooting, and optimization of cell culture and bioassays, such as in-vitro potency.
• Prepare, qualify, and release standards for 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 for cell-based potency assays for AAV-based gene therapy products and other assays.
• Create and maintain clear and concise lab records and documentation.
• Support the authoring of test methods, development reports, study protocols, and validation reports.
• Manage sample inventory and tracking of incoming and outgoing samples.
• Collaborate with team leads and managers to optimize workflow efficiency.
• 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 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.
• Proficiency in cell culture methods, including potency assays, agarose gel electrophoresis, Western blot, SDS-PAGE, and cell culture.
• Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP.
• Ability to operate as part of a team with strong attention to detail.
• Effective written and verbal communication skills.

Pay

The targeted salary range for this position is $78,400 – $98,000 per year. The salary offer is commensurate with education, training, experience, external market conditions, criticality of role, and internal equity.

Schedule

Fully onsite, 4 × 10-hour days per week on a Sunday–Wednesday shift, including coverage for holidays that fall during the shift schedule.