Senior Director, Process Development, RNA & Small Molecule Therapies

Posted 9 Days Ago
Be an Early Applicant
2 Locations
In-Office
222K-278K Annually
Senior level
Biotech
The Role
Lead end-to-end process development for oligonucleotide and siRNA therapies from preclinical through commercialization. Define phase-appropriate strategies, scale-up, tech transfer, CDMO oversight, and QbD-aligned control strategies. Provide technical and regulatory support for CMC documentation, investigations, and validation readiness while collaborating across functions to enable clinical and commercial manufacturing.
Summary Generated by Built In

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 diseases. In 2023, we launched our fourth therapy and the first ever 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 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: https://www.sarepta.com/join-us
 

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 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%.

What Now?

We’re always looking for solution-oriented, critical thinkers.

So, if you’re 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 Sarepta’s 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 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.

Sarepta Therapeutics offers a competitive compensation and benefit package.

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

Skills Required

  • PhD in Chemistry, Chemical Engineering, or related field with 12+ years OR MS in Chemistry, Chemical Engineering, or related discipline with 15+ years of relevant industrial experience
  • Demonstrated experience in RNA-based therapeutics that has led to clinical products
  • Knowledge of chemical linking strategies used in manufacturing processes
  • Expertise in scale-up, GMP manufacturing, tech transfer, and health agency interactions
  • Proven leadership advancing therapies through clinical development into commercialization
  • Deep knowledge of process characterization and QbD-aligned control strategies (CPPs, CMAs)
  • Experience supporting CDMO selection and oversight
  • Experience driving applicable CMC documentation and regulatory submissions
  • Exceptional written and verbal communication skills
  • Strong collaboration and teamwork skills and ability to maintain a safe, efficient, and compliant laboratory environment
  • Ability to travel approximately 15%
  • Authorized to work in the U.S.

Sarepta Therapeutics Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sarepta Therapeutics and has not been reviewed or approved by Sarepta Therapeutics.

  • Fair & Transparent Compensation Feedback suggests pay is considered fair for the role and overall compensation is competitive. Statements referencing good compensation and the company’s positioning of competitive compensation reinforce this perception.
  • Leave & Time Off Breadth Feedback points to generous paid time off, holidays, sick time, and paid parental leave. This breadth supports balance and is consistently highlighted as a strength.
  • Healthcare Strength Coverage spans medical, dental, vision, prescription, disability, and life insurance with added critical illness and accident options. The scope indicates robust healthcare support.

Sarepta Therapeutics Insights

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The Company
HQ: Cambridge, MA
1,464 Employees

What We Do

Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a global biotechnology company on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For information on our Community Guidelines, please visit sarepta.com/community-guidelines. We want to share a reminder with all job seekers and candidates regarding the persistence of recruiting fraud. Please read a message about recruiting fraud and steps you can take to protect yourself here: https://www.sarepta.com/recruiting-fraud

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