Scientist-II Developability & Preformulation

Sarepta Therapeutics•Columbus, OH

7d•$106,400 - $133,000•Onsite

About The Position

The Early Research and Process Development (ERPD) group is seeking a Scientist II with experience in biologics preformulation and developability assessment, with a focus on proteins, antibodies, and antibody-oligonucleotide conjugates (AOCs). This individual will support the assessment of developability for 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 Scientist II 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, and CMC Drug Substance/Drug Product teams to foster a collaborative environment that enables the advancement of robust and scalable manufacturing processes. The Scientist II will contribute formulation recommendations to research, pilot-scale, and commercial-scale manufacturing groups and generate 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 3-5 years or M.S. with 6-8 years of biologics formulation experience
Experience with biologics formulation (e.g., mAbs) is required.
Hands-on experience with protein formulation technologies (e.g., Unchained Labs Big Tuna/Big Kahuna/Junior, Sartorius AMBR Crossflow, Pendotech 5TFF, 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)
Demonstrated ability to work effectively in cross-functional teams and communicate scientific findings to internal stakeholders.
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) formulation 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.
Prior experience in therapeutic protein discovery or biochemistry research.

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.
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.