Scientist-II Developability & Preformulation

Responsibilities

• Plan and execute formulation experiments to assess and optimize the stability of key intermediates and final products throughout the manufacturing process.
• Establish develop ability profiles for candidate molecules, incorporating considerations such as route‑of‑administration.
• Identify formulation‑relevant critical quality attributes for key intermediates and drug product candidates and guide the development of stability‑indicating assays to monitor them.
• Contribute scientific recommendations regarding formulation technologies and instrumentation.
• Support cross‑functional teams by providing recommendations on product handling and storage considerations.
• Prepare and review methods, protocols, and technical reports for regulatory submissions or technology transfer.
• Train and support Research Associates in experimental execution, troubleshooting, and data interpretation.

• Degree in Biochemistry, Biochemical Engineering, Bioengineering, or Chemical Engineering.
• Ph.D. with 3–5 years of biologics formulation experience, or M.S. with 6–8 years.
• Experience with biologics formulation (e.g., mAbs) is required.
• Experience with AOCs or antibody‑drug conjugates (ADCs) formulation is a plus.
• Hands‑on experience with protein formulation technologies (e.g., Unchained Labs Big Tuna/Big Kahuna/Junior, Sartorius AM  Crossflow, Pendotech 5
  
  TFF, Repligen KR2i, etc.).
• Experience with stability and analytical assays to monitor product quality, including SEC, RP, CE‑SDS, cIEF, DLS, DSF, MALS, and mass spectrometry.
• Experience with high‑concentration formulation challenges (e.g., viscosity mitigation strategies, excipient screening, protein‑protein interaction understanding).
• Experience applying Design of Experiments (DoE) principles to formulation development is a plus.
• Demonstrated ability to work effectively in cross‑functional teams and communicate scientific findings to internal stakeholders.
• Proficiency in statistical or data analysis tools (e.g., JMP, Graph Pad, Sigma Plot) is a plus.
• Prior experience in therapeutic protein discovery or biochemistry research.
• Excellent written and verbal communication skills.

Salary: $106,400 – $133,000 per year.

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