Senior Scientist, Developability & Preformulation

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: 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 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 Sareptas 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 patients 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

Were always looking for solution-oriented critical thinkers.

So if youre 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

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This position requires work on site at one of Sareptas facilities in the United States.

The targeted salary range for this position is $118000 - $147500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.