Scientist II, RNA Process Development

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 Opportunity to Make a Difference

• Design and execute synthetic routes for novel small molecules intermediates degradation products and impurities related to RNA drug substance manufacturing.
• Develop scalable robust synthetic procedures; evaluate reaction scope optimization and critical process parameters.
• Identify elucidate and synthesize processrelated impurities and degradants using spectroscopic data (NMR LCMS HRMS IR).
• Collect review and present process data in group settings and apply statistical methodology to evaluate and optimize process operations.
• Support scaleup efforts from milligram to multigram quantities; contribute to tech transfer to internal pilotscale labs or external CRO/CMO partners.
• Evaluate reaction safety solvent selection impurity formation mechanisms and scalability risks.
• Engage in troubleshooting sessions for processes and products manufactured in-house and at CMOs.
• Perform technical review of executed Batch Production Records from CMOs during Technology Transfer.
• Serve as a subject matter expert in cross-functional teams influencing decisions on CMC strategy regulatory filings and risk mitigation.
• Consistently demonstrate an ability to manage a diverse workload to lead and complete assignments according to project schedules and timelines.
• Author and review regulatory and technical documents.
• Other duties as assigned.

More about You

• Advanced degree in Organic Chemistry or related field with 3 5 years of experience.
• Proven track record of leading complex process development projects and influencing technical strategy.
• Expertise in organic synthesis flash chromatography solid-phase synthesis bioconjugation.
• Knowledge with oligonucleotiderelated building blocks or phosphoramidite chemistry (preferred but not required).
• Familiarity with reaction scaleup fundamentals and labtopilot transfer considerations.
• Understanding of QbD principles DoE methodology and statistical modeling tools (JMP Matlab) are a plus.
• Strong knowledge of standard oligonucleotide and organic analytical techniques (HPLC LC-MS NMR TLC GC-MS IR etc.).
• Demonstrated ability to operate independently exercise judgment in ambiguous situations and make strategic decisions.
• Exceptional communication skills for influencing leadership and external stakeholders.
• Commitment to Sareptas cultural values
• Exercises judgment within broadly defined practices and policies in selecting methods techniques and evaluation criteria for obtaining results.
• Demonstrates effective written and verbal communication skills.
• Able to handle multi-task workload and perform duties in a fast-paced environment.

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.