Scientist I, Quality Control

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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.
 

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering 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
 

The Importance of the Role

This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations. The individual will devise, troubleshoot, and validate cell-based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. This role would facilitate activities to coordinate the lot release of samples for early/late phase clinical and commercial AAV therapeutic products.
The incumbent will be involved in the design and execution of novel cell-based assays, writing technical reports, supporting method validation and qualification activities performed in the Sarepta Gene Therapy QC laboratories and/or at contract testing laboratories. The individual will also assist in managing quality events, data trending, and review of quality documents originated at the testing laboratory at Sarepta. Additional responsibilities may include supervising and training junior QC associates as well as the management of their performance.

The Opportunity to Make a Difference

• Development and validation of cell-based assays to interrogate the potency of AAV gene therapy products

• Perform testing of release and stability samples for early and late phase clinical and commercial lots

• Support troubleshooting and optimization of cell and molecular assays, including assay development & validations in accordance with cGMP regulations

• Manage activities related to cell banking and managing cell supplies at Andover or external testing sites

• Author test methods, development reports, study protocols, and validation reports

• Support the method development, transfer and qualification/validation activities associated with the release of viral vector products

• Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites

• Act as company liaison with CMO/CTL/CRO to coordinate in method development and method transfer across various CMO/CTL/CRO sites as needed

• Conduct review of laboratory data and authorization of final reports

• Monitor, review, and trending of stability data

• Perform other related duties incidental to the work described

• Training and mentoring junior associates on the execution and analysis of cell-based assays

More about You

• PhD degree in molecular biology, cell biology or virology with 0 - 3 years relevant experience

• Experience in developing, validating, optimizing and deploying cell-based assays is highly desired

• Strong background in gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting

• Familiarity with primary mammalian cell culture, in particular myoblasts, and a deep understanding of cellular differentiation and commitment

• Operate as a part of a team with experience supervising and/or training individuals in a laboratory environment

• Working experience in a cGMP environment is highly desired

• Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary

• Effective written and verbal communication skills; attention to detail is a must

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What Now?

We’re always looking for solution-oriented, critical thinkers.

So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
 

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This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $96,000 - $120,000 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.