Senior Scientist, Developability & Preformulation

About the Role

The Early Research and Process Development (ERPD) group is seeking a Senior Scientist with deep expertise in biologics preformulation and develop ability assessment, focusing on proteins, antibodies, and antibody‑oligonucleotide conjugates (AOCs). This role is based in Easton, Ohio, with on‑site work at one of Sarepta’s U.S. facilities.

• Assess develop ability of lead molecules through comprehensive evaluations, including biophysical characterization, forced degradation, and short‑term, long‑term, and in‑use stability studies.
• Leverage high‑throughput formulation tools and workflows to characterize product stability across a broad range of conditions (process buffers, excipients, concentrations, hold times, and temperatures).
• Collaborate with Analytical Development to define quality attributes and implement stability‑indicating assays appropriate for early‑stage programs.
• Consider route‑of‑administration factors such as subcutaneous delivery during early formulation assessments (stability, viscosity at high concentrations, enabling approaches).
• Engage cross‑functionally with Upstream and Downstream Process Development, High‑Throughput Automation, Nonclinical Manufacturing, and CMC Drug Substance/Drug Product teams to support robust and scalable manufacturing processes.
• Provide formulation guidance to research, pilot‑scale, and commercial‑scale manufacturing groups, generating scientifically rigorous data packages to inform preclinical and early clinical development.
• Prepare and review methods, protocols, and technical reports for regulatory submissions or technology transfer.
• Train and mentor Research Associates in process design, experimental execution, troubleshooting, and data interpretation.

• Ph.D. in Biochemistry, Biochemical Engineering, Bioengineering, or Chemical Engineering with ≥4years of biologics formulation experience, or M.S. with ≥9years.
• Experience with AOCs or antibody‑drug conjugates (ADCs) is a plus.
• Proven technical expertise in protein formulation technologies (e.g., Unchained Labs, Sartorius AM  Crossflow, Pendotech, Repligen KR2i).
• Expertise in stability and analytical assays to monitor product quality (SEC, RP, CE‑SDS, cIEF, DLS, DSF, MALS, mass spectrometry).
• Experience addressing high‑concentration formulation challenges (viscosity mitigation, excipient screening, protein‑protein interaction).
• Application of Design of Experiments (DoE) principles to formulation development is a plus.
• Track record of cross‑functional collaboration and providing scientifically informed guidance.
• Proficiency with statistical or data analysis tools (JMP, Graph Pad, Sigma Plot) is a plus.
• Excellent written and verbal communication skills.
• Authorized to work in the United States.

The targeted salary range for this position is $118,000 – $147,500 per year. Candidates will also receive a competitive benefits package commensurate with Sarepta’s compensation philosophy and includes support for physical, emotional, and financial wellness.

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