The Importance of the Role
The Senior Director, Process Development, RNA & Small Molecule Therapies 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 in 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 continue to advance Sarepta’s mission in advancing valuable therapies to patients in need
More about You
PhD in Chemistry, Chemical Engineering, or 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 crossfunctional peers and maintain a safe, efficient, and compliant laboratory environment.
Deep knowledge of process characterization and control strategies.
Ability to travel approximately 15%.
What Now?
Were always looking for solution-oriented, critical thinkers.
So, if youre 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-Hybrid
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This position is hybrid, you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.
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 Sareptas 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.
