Senior Scientist, Developability & Preformulation

Sarepta Therapeutics•Columbus, OH

2d•Onsite

About The Position

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. Sarepta provides a creative culture that invites you to be the best that you can be and is committed to making a difference in patient’s lives. Join us at the Genetic Therapy Center of Excellence here in Easton, Ohio.

Requirements

Degree in Biochemistry, Biochemical Engineering, Bioengineering, or Chemical Engineering
Ph.D. with ≥ 4 years of biologics formulation experience, or M.S. with ≥ 9 years.
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)
Track record of cross-functional collaboration and providing scientifically informed guidance to internal and external teams.
Prior experience in therapeutic protein discovery or biochemistry research.
Excellent written and verbal communication skills.
Candidates must be authorized to work in the U.S.

Nice To Haves

Experience with AOCs or antibody-drug conjugates (ADCs) is a plus.
Experience applying Design of Experiments (DoE) principles to formulation development is a plus.
Proficiency in statistical or data analysis tools (e.g., JMP, GraphPad, SigmaPlot) is a plus.

Responsibilities

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.