Senior Director, Analytical Development, Separation Science and Protein Chemistry

Sarepta Therapeutics•Andover, MA

1d•Onsite

About The Position

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. 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 HPLC and Mass Spectrometry trained individual with 10+ years experience in regulated environment. Previous management of a team >5 members is required The Opportunity to Make a Difference The Senior Director will oversee the development of HPLC and Mass spectrometry based analytical methods for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug substance, Drug Product including in-process, release and stability testing. The individual will direct and manage the activities related to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs. The person would oversee the activities in developing purity and impurity characterization methods and excipient analysis. This role will represent Analytical Development in high‑level internal meetings and coordinate method transfers to internal QC laboratories and external GMP testing sites. The Senior Director will oversee the creation of protocols for freeze–thaw studies, accelerated degradation studies, and method qualification and validation in collaboration with the Sarepta Head of Quality Control or their designee. They will also support troubleshooting of analytical methods at CROs/CTOs and may facilitate the transfer of complex analytical assays into Sarepta’s GMP laboratories. Additionally, the Senior Director will lead the writing and compilation of regulatory documents to support product development and registration. More about You Individual will report to the Vice President of Analytical Sciences. 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. #LI-Onsite #LI-ES1 This position requires work on site at one of Sarepta’s facilities in the United States. The targeted salary range for this position is $222,400 - $278,000 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.

Requirements

HPLC and Mass Spectrometry trained individual with 10+ years experience in regulated environment.
Previous management of a team >5 members is required
Candidates must be authorized to work in the U.S.

Responsibilities

Oversee the development of HPLC and Mass spectrometry based analytical methods for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug substance, Drug Product including in-process, release and stability testing.
Direct and manage the activities related to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs.
Oversee the activities in developing purity and impurity characterization methods and excipient analysis.
Represent Analytical Development in high‑level internal meetings and coordinate method transfers to internal QC laboratories and external GMP testing sites.
Oversee the creation of protocols for freeze–thaw studies, accelerated degradation studies, and method qualification and validation in collaboration with the Sarepta Head of Quality Control or their designee.
Support troubleshooting of analytical methods at CROs/CTOs and may facilitate the transfer of complex analytical assays into Sarepta’s GMP laboratories.
Lead the writing and compilation of regulatory documents to support product development and registration.