Senior Director, Product Development, RNA Therapies

Why Sarepta Why Now

The promise 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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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 all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range 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: Importance of the Role

The Senior Director Product Development is a strategic and operational leader accountable for establishing a product development laboratory and delivering robust scalable and compliant RNA manufacturing processes across Sareptas 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.

The Opportunity to Make a Difference

• Establish a state of the art flexible product development laboratory for oligonucleotide manufacture using standard and novel amidites.

• Establish a team capable of producing various modification to attach 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 andvalidationreadiness.

• Develop platform approaches and operational strategies to improve efficiency and effectiveness of advancing Sareptas portfolio.

• Provide technical oversight and support in monitoring performance and in resolving investigations.

• EnsureQbD-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 Sareptas 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 in RNA manufacturing and process development oversight.

• 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

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 $222400 - $278000 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.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.