Senior Associate Scientist, Formulation Development (Peptide and Antibody)

Role Summary

Senior Associate Scientist, Formulation Development (Peptide and Antibody) at Regeneron. Responsible for characterizing drug candidates and developing antibody and peptide formulations to enable preclinical and clinical development, and commercialization. Perform 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

• This role requires a 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 keen analytical and problem-solving skills are desired. The ability to design and execute experiments, as well as interpret, document, and communicate results with minimal supervision is required. Experience with protein stability, structure or biophysical studies is desirable. Hands-on experience and troubleshooting proficiency with applying chromatography (SEC, IEX, RP, HIC) and/or biophysical techniques such as light scattering (DLS, MALS, SLS) and AUC for studying proteins is desirable.

Skills

• Excellent interpersonal, oral, and written communication skills.
• Ability to design and execute experiments, interpret results, and communicate with minimal supervision.
• Proficiency in biochemical and biophysical methods and data analysis.

Education

• BS in Biochemistry, Chemistry, Biophysics, Protein Chemistry, Pharmaceutical Science, or related field; or MS in above fields.

Additional Requirements

• Travel expectations or physical demands are not specified as essential in this description.