Senior Associate Scientist, Formulation Development (Peptide and Antibody)

Role Summary

Sr. Associate Scientist in Regeneron's Formulation Development Group (FDG) to support early to late-stage development for biologics including antibodies and peptide modalities. Responsible for characterizing drug candidates and developing antibody and peptide formulations to enable preclinical and clinical development, and commercialization. Performs research on product characterization, formulation, and analytical technology development.

Responsibilities

• Design and execute phase-appropriate formulation development studies, such as formulation screening, stability, and compatibility studies, to support formulation and drug product development for early and late-stage development programs, including antibodies and peptides.
• Develop and apply fit-for-purpose analytical, biochemical, and biophysical methods to support phase-appropriate formulation development, manufacturing process development, and research stability testing.
• Conduct biochemical and biophysical assessments and pre-formulation studies to support evaluation of preclinical drug candidates.
• Provide technical support for development, technology transfer and manufacture of drug substance and drug product and collaborate with cross-functional teams.
• Collaborate with scientific colleagues in conducting research and development work and investigating and solving development problems.
• Author and review formulation development sections of regulatory and technical documents, study reports, technology transfer documents, and manuscripts for publication.
• Utilize statistical science knowledge for study design and data analysis.
• Present work internally at group, department and cross functional meetings and at external conferences.
• Participate in research and technology innovation projects.
• Participate in the general laboratory and instrument maintenance.

Qualifications

• Required: BS degree in Biochemistry, Chemistry, Biophysics, Protein Chemistry, Pharmaceutical Science, or a related discipline with 6+ years of industry or academia working experience, or an MS degree in the above-mentioned fields with 3+ years of hands-on research experience. Experience in protein/peptide chemistry and protein/peptide characterization with analytical and problem-solving skills.
• Required: Ability to design and execute experiments, interpret, document, and communicate results with minimal supervision.
• Preferred: Experience with protein stability, structure or biophysical studies; hands-on experience with chromatography (SEC, IEX, RP, HIC) and/or biophysical techniques such as light scattering (DLS, MALS, SLS) and AUC for studying proteins.

Education

• BS degree in Biochemistry, Chemistry, Biophysics, Protein Chemistry, Pharmaceutical Science, or a related discipline with 6+ years of relevant experience, or
• MS degree in the above-mentioned fields with 3+ years of hands-on research experience.