Scientist-II Developability & Preformulation

Sarepta Therapeutics; Columbus (OH); On-site; USD 106,400 - 133,000; Full time

Benefits offered by this job

Equal Opportunity Employer

e‑Verify participation

Job summary

Sarepta Therapeutics in Columbus, Ohio, seeks a seasoned Biologics Formulation Scientist to lead formulation experiments and stability studies for key intermediates and final products. You will develop developability profiles, optimize routes, and collaborate across teams to ensure scalable, compliant processes. The role requires Ph.D.

with 3–5 years or M.S. with 6–8 years in biologics formulation, with hands-on use of protein formulation tech and analytical assays.

Qualifications

• Ph.D. with 3–5 years 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 and stability/analytical assays.

Responsibilities

• Plan and execute formulation experiments to assess stability of intermediates and final products throughout manufacturing.
• Establish developability profiles for candidate molecules considering route-of-administration.
• Identify formulation-relevant QC attributes and guide stability-indicating assay development.
• Contribute technical recommendations on formulation technologies and instrumentation.
• Support cross-functional teams with product handling and storage recommendations.
• 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.

Skills

Biochemistry

Biochemical Engineering

Protein formulation

DoE principles

Cross-functional collaboration

Statistical/data analysis (JMP/Graph)

Excellent communication

Education

Ph.D. in Biochemistry/related formulation field

M.S. in Biochemistry/related field

Tools

Unchained Labs Big Tuna/Big Kahuna/Junior

Sartorius AMBR Crossflow

Pendotech 5TFF

Repligen KR2i

Job description

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 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.

Qualifications

• 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 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).
• 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, GraphPad, SigmaPlot) 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.