Sr Associate Scientist, Formulation Development

Role Summary

Sr Associate Scientist, Formulation Development. Regeneron's Formulation Development Group supports pre-clinical, clinical, and commercial formulation and drug product development for various modalities. Apply biochemical and biophysical methods to carry out developability assessment and formulation development studies on monoclonal antibody-based therapeutics, to support drug substance and drug product development.

Responsibilities

• Conduct developability assessment studies for monoclonal antibodies, bioconjugates, and peptides using biophysical and biochemical techniques to identify critical quality attributes for formulation and drug product development.
• Design and independently execute phase-appropriate formulation development studies, including formulation screening, stability and compatibility studies, to support drug product development for early and late-stage programs.
• Characterize drug product formulations (lyophilized or liquid) to support process development and manufacturing of clinical drug substances and drug products.
• Document findings and lab records in electronic laboratory notebook following organizational best practices and policies.
• Contribute to formulation development technical reports to provide insights for process development and manufacturing of clinical drug substances and drug products.
• Participate in meetings and present study results in cross-functional and department meetings.
• Author protocols and technical documents for internal use and support regulatory filings.
• Participate in general laboratory and instrument maintenance.

Qualifications

• B.S. with 4+ years or M.S. with minimum 2 years of relevant post-degree laboratory experience in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or related discipline. Relevant industry experience preferred.
• Strong knowledge with protein/peptide chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development, and biomolecule product development.
• Hands-on experience with biochemical and biophysical techniques for protein characterization, including chromatography (SEC, IEX, RP), viscosity, gel electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), spectroscopy (UV-Vis, CD, AUC, fluorescence), and thermostability characterization (DSC, DSF) is desirable.

Skills

• Data-driven decision making and technical problem solving
• Data visualization and clear communication of figures and tables
• Timely communication of critical data to supervisor and team
• Prioritization and multi-task management
• Detail-oriented, self-motivated, effective team player
• Excellent oral and written communication

Education

• B.S. or M.S. in a relevant science field as specified above

Additional Requirements

• Travel or physical demands not specified as essential in provided content