Senior Scientist, Developability & Preformulation

The Importance of the Role

The Early Research and Process Development (ERPD) group is seeking a Senior Scientist with deep expertise in biologics preformulation and developability assessment, with a focus on proteins, antibodies, and antibody-oligonucleotide conjugates (AOCs).

This individual will be responsible for assessing the developability of lead molecules through comprehensive evaluations, including biophysical characterization, forced degradation, and short-term, long-term, and in-use stability studies.

The successful candidate will leverage high-throughput formulation tools and workflows to characterize product stability across a broad range of conditions, including process buffers, excipients, concentrations, hold times, and temperatures.

In collaboration with Analytical Development, the candidate will help define quality attributes and implement stability-indicating assays appropriate for early-stage programs.

The Senior Scientist will also consider route-of-administration factors, such as subcutaneous delivery, during early formulation assessments (e.g., stability and viscosity at high concentrations, potential enabling approaches).

This role requires strong cross-functional engagement, working closely with Upstream and Downstream Process Development, High-Throughput Automation, Nonclinical Manufacturing, and CMC Drug Substance/Drug Product teams to foster a collaborative environment that enables the advancement of robust and scalable manufacturing processes.

The Senior Scientist will provide formulation guidance to research, pilot-scale, and commercial-scale manufacturing groups generating scientifically rigorous data packages to inform preclinical and early clinical development and enable downstream CMC strategy for Sarepta’s genetic therapy engine.

What You Will Do

• Plan and execute formulation experiments to assess and optimize the stability of key intermediates and final products throughout the manufacturing process.
• Establish developability profiles for candidate molecules, incorporating considerations for 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.
• Provide expert guidance on formulation technologies and instrumentation to support informed decision-making.
• Offer product handling guidance to cross-functional teams.
• 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.

Qualifications

• Degree in Biochemistry, Biochemical Engineering, Bioengineering, or Chemical Engineering
• Ph.D. with ≥ 4 years of biologics formulation experience, or M.S. with ≥ 9 years
• Experience with AOCs or antibody-drug conjugates (ADCs) is a plus
• Proven technical expertise in protein formulation technologies (e.g., Unchained Labs Big Tuna/Big Kahuna/Junior, Sartorius AMBR Crossflow, Pendotech 5TFF, Repligen KR2i, etc.)
• Expertise in 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
• Track record of cross-functional collaboration and providing scientifically informed guidance to internal and external teams
• Proficiency in statistical or data analysis tools (e.g., JMP, GraphPad, SigmaPlot) is a plus
• Prior experience in therapeutic protein discovery or biochemistry research
• Excellent written and verbal communication skills