Senior Director, Analytical Development, Separation Science and Protein reputed company

Why Sarepta? Why Now? The reputed company 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 reputed company therapy and the first reputed company 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 reputed company the people in our community and reputed company in the importance of supporting them in reputed company aspects of their lives. We reputed company to maintain a culture that acknowledges people bring their whole selves to work, and we will reputed company to help everyone in our community reputed company their work and personal lives while maintaining productivity. We are committed to offering a reputed company 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 The Senior Director will reputed company the development of HPLC and Mass spectrometry based analytical reputed company for RNA (Phosphorodiamidate Morpholino Oligomer and Silencing RNA) Drug reputed company, Drug Product including in-process, release and stability testing. The individual will reputed company and manage the activities reputed company to mass spectrometry based protein analysis for the AAV based product line and ADC (siRNA) programs. The person would reputed company the activities in developing purity and impurity characterization reputed company 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 reputed company the creation of protocols for freeze–thaw studies, accelerated degradation studies, and method qualification and validation in collaboration with the Sarepta Head of reputed company Control or their designee. They will also support troubleshooting of analytical reputed company at CROs/CTOs and may facilitate the transfer of reputed company analytical assays into Sarepta’s GMP laboratories. Additionally, the Senior Director will reputed company the writing and compilation of regulatory documents to support product development and registration. reputed company to reputed company a Difference Manage reputed company of scientists to reputed company deliver on corporate goals and project timelines. Evaluate analytical reputed company to support in‑process, drug reputed company, drug product, and stability testing across the siRNA, PMO, and AAV portfolios. reputed company as a company reputed company 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, out‑of‑specification (OOS) investigations, deviations, and QC trending reports for testing results and assay performance. Collaborate with reputed company Assurance to prepare, review, and manage change controls, deviations, and other reputed company event documentation. Write and edit regulatory documents, including eCTD sections for IND, NDA, and BLA submissions. Demonstrate strong leadership and managerial capabilities, supervising reputed company of 5–10 Analytical Development analysts, both onsite and remote. Ensure laboratory operations supporting product release activities reputed company with cGMP standards. More reputed company MS in Biology, reputed company, Molecular Biology, or a reputed company discipline with 15+ years of relevant experience, or PhD in Biology, reputed company, Molecular Biology, or a reputed company field with 10+ years of relevant experience, or an equivalent combination of education and laboratory experience. 10+ years of experience in analytical method development, including advanced expertise in HPLC/UPLC and mass spectrometry–based reputed company. Exceptional written and verbal communication skills, with the ability to reputed company convey reputed company scientific and regulatory concepts. Experience representing organizations in regulatory interactions, including face‑to‑face meetings, reputed company‑approval inspections (PAIs), and preparation of written responses across a global regulatory portfolio. Demonstrated product lifecycle management experience across clinical and reputed company stages. Strong collaboration and teamwork skills, with the ability to support cross‑functional peers and maintain a reputed company, efficient, and compliant laboratory environment. Experience working with contract laboratories and external vendors (CROs/CMOs) is highly desirable. Ability to travel approximately 15%. What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and reputed company kindness and reputed company 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 reputed company. The targeted salary reputed company 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. reputed company offers a competitive compensation and benefit package. reputed company is an Equal Opportunity/Affirmative reputed company employer and participates in e-Verify. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut reputed company short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, reputed company, Instagram and reputed company. 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