Sr. Scientist, Downstream and Biologics Formulation Development

Key Responsibilities

• Lead formulation development for biologics, including pre-formulation assessments, excipient screening, and stability studies.
• Demonstrated experience in formulation development for complex biologic modalities—including antibody–drug conjugates (ADCs)—with understanding of modality-specific stability and developability challenges is highly advantageous.
• Lead downstream process development for biologics, including capture chromatography, polishing chromatography, viral inactivation/filtration, and tangential flow filtration (TFF).
• Extensive hands-on experience with analytical techniques for protein characterization, including DLS, DSF, SEC, CE, rheology, and spectroscopy.
• Design and interpret analytical testing strategies including HPLC (SEC & IEX), CE-SDS, SDS-PAGE, UV spectroscopy, and other biophysical assays to support process development and formulation studies.
• Able to identify and mitigate formulation risks including precipitation and chemical degradation.
• Design experiments, analyze data, and prepare technical protocols, reports, and development summaries.
• Establish and drive scientific strategy, workflows, and best practices for early- to late-stage biologics formulation development, with the ability to operate independently in a dynamic, fast-paced, client-facing environment with evolving priorities.
• Serve as a technical subject matter expert (SME) in client engagements, including proposals, presentations, and project reviews; prior line management or informal leadership experience is advantageous.
• Collaborate effectively with cross-functional teams to align project timelines, priorities, and resource planning.
• Mentor and develop junior scientists and technical staff, and support onboarding of new team members.
• Evaluate and implement new technologies and platform approaches to enhance internal capabilities and drive innovation. Ensure compliance with applicable quality, regulatory, and safety standards.
• Perform additional responsibilities as required to support evolving business and project needs.

Minimum Qualifications

• Master’s degree/PhD degree in Biochemistry, Chemistry, or related field and minimum 4-6 years of relevant experience and demonstrated working knowledge of scientific principles.
• Prior experience in formulation development, stability studies, and analytical characterization of biologics or strong background in biochemical and biophysical characterization of proteins with deep understanding of protein structure and function.
• Experience in development of ultra-high concentration and pre-developability assessment.
• Proven record of strong technical writing and communication skills.
• Ability to thrive in a dynamic, cross-functional environment.

Preferred Qualifications

• Ph.D. in Biochemistry, Chemistry, or related field with 4-6 years of industry experience, or M.S. with 6-10 years of experience.
• Prior experience in formulations process development and/or downstream process development of biologics is a plus.
• Experience mentoring or leading scientific staff preferred.
• Candidates with strong expertise in either biologics formulation development or downstream process development will be considered, with opportunities to contribute across both areas.