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 Quality Control (QC) activities conducted both at the Contract Test Laboratories (CTLs) and internally for molecular biology and biochemical analyses. This position involves managing up to three direct reports. The individual will be responsible for supporting test method transfer and technical interpretation of data supporting release of AAV gene therapy products. Oversight of chemical and biological test methods including but not limited to:

• Sanger sequencing
• Polymerase Chain Reaction (PCR) (qPCR, ddPCR)
• Molecular cloning
• Western blotting
• Bicinchoninic Acid Assay (BCA)
• SDS-PAGE
• Protein purification
• Endotoxin
• ELISA
• Virus purification
• Analytical Ultracentrifugation (AUC)
• Capillary electrophoresis
• Other cell-based test methods

The individual will be responsible for reviewing release data, writing technical reports, supporting analytical method transfer activities conducted at the CTLs. The individual will also assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner. This job requires exceptional organizational skills and excellent communication skills, as well as the ability to balance changing priorities and tight timelines.

The Opportunity to Make a Difference

• Manage release testing of commercial and clinical products at contract testing laboratories.
• Review gene therapy product release and stability data generated at the CTLs and Sarepta.
• Generate product release Certificate of Analysis (CoA) and associated GMP documentation.
• Manage QC lot release metrics and support lot disposition.
• Collaborate with cross functional teams to establish project timelines and priorities, ensure QC deliverables and timelines are met.
• Author and review Quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
• Manage up to three direct reports.
• Support the method, transfer and qualification/validation activities associated with the release of bacterial plasmids, cell banks, and viral vector drug products.
• Support CMC regulatory functions.
• Trend data for qualified materials, release products, and stability products.
• Review scientific literature for incorporation into technical reports and laboratory investigations.

More About You

BS degree in a scientific discipline with 5-8 years of related experience. MA/MS degree with 4+ years of related experience preferred. Working experience in a cGMP environment is required. Understanding of PCR methods, ELISA, Capillary Electrophoresis, SDS-PAGE, Western blotting, Sanger Sequencing, and cell-based assays is necessary. Experience in virus amplification and purification is desirable. Experience in developing, validating and deploying molecular biology test methods is useful. Proven ability to work independently and effectively handle multiple priorities is a must. Must have effective written and verbal communication skills.

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.

This position is hybrid; you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

Salary Information

The targeted salary range for this position is $112,000 - $140,000 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.