Scientist II, RNA Process Development

Scientist II, RNA Process Development page is loaded## Scientist II, RNA Process Development remote type:
Onsite locations:
Andover, MA:
Bedford, MAtime type:
Full time posted on:
Posted 3 Days Agojob requisition :
R-03133

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:
** The Importance of the Role
** The Scientist II, RNA Process Development will contribute 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 will focus 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.
** 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 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.
** 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 oligonucleotide‑related building blocks or phosphoramidite chemistry (preferred but not required).
* Familiarity with reaction scale‑up fundamentals and lab‑to‑pilot transfer considerations.
* Understanding of QbD principles, DoE methodology, and statistical modeling tools (JMP, Matlab) are a plus.
*…