We are seeking a highly motivated Principal Scientist within the Formulation Development Group (FDG) of Regeneron Pharmaceutical Inc. at Tarrytown, NY. The Principal Scientist leads formulation and drug product development that may include candidate screening and selection for preclinical and Phase 1 clinical studies, developing formulations for Phase 2/3 clinical studies and commercialization.

• Lead formulation and drug product development activities for multiple programs of different modalities, such as peptides, monoclonal antibodies or AAVs, in collaboration with analytical and drug product process development and other cross functional teams.
• Design and conduct biochemical and biophysical characterization and pre-formulation studies to support evaluation of preclinical drug candidates and developing preclinical and FIH formulations
• Independently designs and conducts stability studies and other experiments to support formulation development and stability testing in various phases
• Develops and applies analytical methods to support product characterization, formulation development, and stability testing of peptide, protein based biologics and gene therapy modalities, such as AAV.
• Serve as a program lead and subject matter of experts at the cross functional research, CMC and program teams
• Presents work at group, department and inter-department meetings, and shares knowledge and expertise of formulations development at cross-functional team meetings.
• Authors and reviews formulation development sections of regulatory and technical documents, study reports and technology transfer documents
• Mentors and manages research associates as needed
• Seeks out, recognizes and assesses new technologies to improve formulation development and analytical characterization
• Conducts research (problem solving, characterizing protein stability, etc), presents at external conferences and publish work

This Role May Be for You If:

• You have hands-on experience in peptides, protein, antibodies, AAV, or other gene and cell therapies in a biopharmaceutical setting
• You have strong technical knowledge base and proven experience with biophysical/biochemical characterization, bioanalytical method development or biomolecule product development.
• You have hands-on experience and trouble-shooting proficiency with analytical and characterization techniques for biomolecules, such as column chromatographic (HPLC/UPLC), capillary electrophoresis and/or biophysical techniques (such as DLS, CD, FTIR, DSC, AUC) for protein characterization.
• You have a passion for science with motivation for making contributions and thrive in fast-paced collaborative team environment.
• You are capable of multi-tasking, working both independently and within a collaborative environment.
• You excel when working in a fast-paced environment.
• You have excellent verbal and written communication and organization skills, with a proven track record.