Senior Scientist, Developability & Preformulation at Sarepta Therapeutics

Columbus, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Jul, 26

Salary

147500.0

Posted On

26 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biologics preformulation, Developability assessment, Biophysical characterization, Forced degradation, Stability studies, High-throughput formulation, Protein formulation, Analytical assays, Design of experiments, Statistical analysis, Biochemistry, Biochemical engineering, Mass spectrometry, Viscosity mitigation, Technical writing, Mentorship

Industry

Biotechnology Research

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 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. 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. 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. More about You Degree in Biochemistry, Biochemical Engineering, Bioengineering, or Chemical Engineering Ph.D. with ≥ 4 years of biologics formulation experience, or M.S. with ≥ 9 years. Experience with AOCs or antibody-drug conjugates (ADCs) is a plus. 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) Experience applying Design of Experiments (DoE) principles to formulation development is a plus. Track record of cross-functional collaboration and providing scientifically informed guidance to internal and external teams. 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. 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-Onsite Blank This position requires work on site at one of Sarepta’s facilities in the United States. The targeted salary range for this position is $118,000 - $147,500 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. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Responsibilities

The Senior Scientist will assess the developability of lead molecules through comprehensive biophysical characterization and stability studies. They will also collaborate cross-functionally to define quality attributes and provide formulation guidance to support preclinical and clinical development.