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Scientist-II Developability & Preformulation

Scientist-II Developability & Preformulation

Sarepta Therapeutics

Columbus, OH

Full-time

Posted 25 days ago

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

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

  • 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 andoptimizethe stability of key intermediates and final products throughout the manufacturing process.

    • Establish developability profiles for candidate molecules, incorporating considerations for route-of-administration.

    • Identifyformulation-relevant critical quality attributes for key intermediates and drug productcandidates andguide the development of stability-indicating assays tomonitorthem.

    • Contribute scientific recommendationsregardingformulation 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. with3-5yearsor M.S. with6-8yearsof biologics formulation experience,

  • Experience withbiologicsformulation(e.g.,mAbs) isrequired. Experience withAOCs or antibody-drug conjugates (ADCs)formulationis a plus.

  • Hands-on experience with protein formulation technologies(e.g., Unchained Labs Big Tuna/Big Kahuna/Junior, Sartorius AMBR Crossflow,Pendotech5TFF, Repligen KR2i, etc.).

  • Experience with stability and analytical assaystomonitorproduct 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.

  • Proficiencyin 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.

What Now?

We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-OnsiteThis 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.

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