Job Summary 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 and drug product, including in‑process, release, and stability testing. The individual will direct and manage mass spectrometry based protein analysis for the AAV‑based product line and ADC (siRNA) programs, develop purity and impurity characterization methods, and coordinate method transfers to internal QC laboratories and external GMP testing sites. Responsibilities Lead a team of 5–10 analytical development scientists, both onsite and remote. Evaluate analytical methods to support in‑process, drug substance, drug product, and stability testing across the siRNA, PMO, and AAV portfolios. Serve as a company liaison with contract laboratories, coordinating method transfers and overseeing method qualification and validation activities. Assess QC needs and generate essential testing documentation, including SOPs, change controls, laboratory investigations, OOS investigations, deviations, and QC trending reports. Collaborate with Quality Assurance to prepare, review, and manage change controls, deviations, and other quality event documentation. Write, edit, and compile regulatory documents, including eCTD sections for IND, NDA, and BLA submissions. Coordinate freeze‑thaw studies, accelerated degradation studies, and method qualification and validation in collaboration with the Head of Quality Control. Support troubleshooting of analytical methods at CROs/CTOs and facilitate transfer of complex analytical assays into GMP laboratories. Ensure laboratory operations supporting product release activities comply with cGMP standards. Qualifications MS in Biology, Chemistry, Molecular Biology, or a related discipline with 15+ years of relevant experience, or a PhD with 10+ years of relevant experience, or an equivalent combination of education and laboratory experience. 10+ years of experience in analytical method development, with advanced expertise in HPLC/UPLC and mass spectrometry‑based methods. Exceptional written and verbal communication skills, able to convey complex scientific and regulatory concepts. Experience representing organizations in regulatory interactions, including pre‑approval inspections and preparation of written responses. Demonstrated product lifecycle management experience across clinical and commercial stages. Strong collaboration and teamwork skills, with the ability to support cross‑functional peers and maintain a safe, efficient, and compliant laboratory environment. Experience working with contract laboratories and external vendors (CROs/CMOs) highly desirable. Ability to travel approximately 15%. Location and Compensation Work on site at one of Sarepta’s facilities in the United States. Salary range: $222,400 – $278,000 per year. Benefits Competitive compensation includes physical and emotional wellness, financial wellness, and caregiver support. Additional benefits are available on the company website. Equal‑Opportunity Statement Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e‑Verify. #J-18808-Ljbffr