Scientist-II Developability & Preformulation

Biopharma Careers; North Carolina; On-site; USD 106,000 - 133,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics, located in the United States, seeks a Scientist II in its ERPD group to advance biologics preformulation and developability assessments for proteins, antibodies, and AOCs. You will help evaluate lead candidates via stability studies, biophysical characterization, and high-throughput formulation workflows.

The role involves cross-functional collaboration with Upstream/Downstream Process Development and analytical teams to enable scalable manufacturing, with on-site work in

Qualifications

• Degree in Biochemistry or related field required.
• Ph.D. with 3–5 years of biologics formulation experience or MS with 6–8 years preferred.
• Experience with biologics formulation (mAbs) required; AOCs/ADCs is a plus.

Responsibilities

• Plan and execute formulation experiments to assess stability of intermediates and products.
• Establish developability profiles with route-of-administration considerations.
• Identify critical quality attributes and develop stability-indicating assays.
• Contribute formulations knowledge on technologies and instrumentation.
• Support cross-functional teams with product handling and storage guidance.
• Prepare methods, protocols and reports for regulatory or tech transfer.
• Train and support junior staff in experiments, troubleshooting, and data interpretation.

Skills

Cross-functional collaboration

Formulation development

Stability studies

Statistical analysis

DoE principles

Data interpretation

Analytical methods

Education

Ph.D. in Biochemistry/related

M.S. in Biochemistry/related

Tools

Unchained Labs Big Tuna

Sartorius AMBR Crossflow

Repligen KR2i

cIEF

Job description

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

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.

The Opportunity to Make a Difference

• 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.

More about You

• 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. 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.

This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $106,400 - $133,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

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