Scientist II, RNA Process Development

Role Summary

The Scientist II, RNA Process Development contributes to Sarepta’s small‑molecule and oligonucleotide‑related chemistry efforts, supporting development and characterization of intermediates, impurities, and reference standards that enable RNA Drug Substance manufacturing (PMO, PPMO, PMOx, and siRNA). The role focuses on synthetic route design, impurity identification and synthesis, bioconjugation, and bench‑to‑pilot‑scale execution. The ideal candidate brings strong problem‑solving skills, hands‑on synthetic chemistry expertise, and the ability to work cross‑functionally in a fast‑paced development environment.

This role will directly influence synthetic strategy and contribute to the advancement of Sarepta’s RNA manufacturing platforms.

Location:

On‑site at a Sarepta facility in the United States.

• 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 process‑related impurities and degradants using spectroscopic data (NMR, LC‑MS, HRMS, IR).
• Collect, review, and present process data in group settings and apply statistical methodology to evaluate and optimize process operations.
• Support scale‑up efforts from milligram to multi‑gram quantities; contribute to tech transfer to internal pilot‑scale 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.

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

• Advanced degree in Organic Chemistry or related field.

• On‑site work at a Sarepta facility in the United States.