Senior Director, RNA & Molecule Therapies
Listed on 2026-06-13
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Engineering
Regulatory Compliance Specialist, Chemical Engineer, Process Engineer
The Importance of the Role
The Senior Director, Process Development is a strategic and operational leader accountable for establishing and delivering robust, scalable, and compliant manufacturing processes across Sarepta’s expanding portfolio of oligonucleotide therapeutics and siRNA modalities.
This role defines and executes phase‑appropriate process development strategies from early development through commercialization, ensuring alignment with regulatory expectations, technical excellence, and business objectives.
The Opportunity to Make a Difference- Own and execute end‑to‑end process development strategies across modalities from preclinical through commercialization.
- Lead teams covering process development, scale‑up, tech transfer, regulatory support, and validation readiness.
- Develop platform approaches and operational strategies to improve efficiency and effectiveness of advancing Sarepta’s portfolio.
- Provide technical oversight and support in monitoring performance and resolving investigations.
- Ensure QbD‑aligned control strategies (CPPs, CMAs).
- Support CDMO selection and oversight.
- Drive applicable CMC documentation and regulatory submissions.
- Collaborate with leadership across the organization to advance Sarepta’s mission in delivering valuable therapies to patients in need.
- PhD in Chemistry, Chemical Engineering, or a related field with 12+ years of experience or MS in Chemistry, Chemical Engineering, or a related discipline with 15+ years of relevant industrial experience.
- Demonstrated experience in RNA‑based therapeutics that has led to clinical products.
- Demonstrated knowledge of chemical linking strategies used in manufacturing processes.
- Strong expertise in scale‑up, GMP manufacturing, tech transfer and health agency interactions.
- Proven leadership in advancing therapies through clinical development and into commercialization.
- Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific and regulatory concepts.
- Strong collaboration and teamwork skills, with the ability to support cross‑functional peers and maintain a safe, efficient, and compliant laboratory environment.
- Deep knowledge of process characterization and control strategies.
- Ability to travel approximately 15%.
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Salary range: $222,400 - $278,000 per year. This position is hybrid, requiring on‑site work at a Sarepta facility in the United States and occasional attendance at company‑sponsored in‑person events. Candidates must be authorized to work in the U.S.
Equal Opportunity StatementSarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e‑Verify.
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