Director, Process Development, RNA Therapeutics

Sarepta Therapeutics•Andover, MA

10d•$185,600 - $232,000•Hybrid

About The Position

The Director, Process Development is a strategic and operational leader accountable for establishing a small-scale process development laboratory and delivering robust, scalable, and compliant RNA 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 for RNA based therapeutic modalities.

Requirements

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 in RNA manufacturing and process development oversight.
Demonstrated experience in RNA based therapeutics, siRNA is preferred, 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%.

Responsibilities

Establish a state-of-the-art flexible process development laboratory for oligonucleotide manufacture using standard and novel amidites.
Establish a team capable of producing various modifications to conjugate ligands, peptides, lipids and antibodies to oligonucleotides.
Develop and oversee relationships with commercial grade manufacturers for linkers, novel ligands and peptides
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