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Senior Associate Scientist, Formulation Development (Peptide and Antibody)

Regeneron
Full-time
Remote friendly (Tarrytown, NY)
United States
Clinical Research and Development

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Role Summary

Senior Associate Scientist, Formulation Development (Peptide and Antibody) at Regeneron. Supports early to late-stage development for biologics including antibodies and peptide modalities by characterizing drug candidates and developing formulations for preclinical and clinical development, as well as research on product characterization, formulation, and analytical technology development.

Responsibilities

  • Design and execute phase-appropriate formulation development studies, including formulation screening, stability, and compatibility studies for early and late-stage development programs (antibodies and peptides).
  • Develop and apply fit-for-purpose analytical, biochemical, and biophysical methods to support formulation development, manufacturing process development, and 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; collaborate with cross-functional teams.
  • Collaborate with scientific colleagues in conducting research and development work 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 general laboratory and instrument maintenance.

Qualifications

  • Required: BS degree in Biochemistry, Chemistry, Biophysics, Protein Chemistry, Pharmaceutical Science, or related discipline with 6+ years of industry or academia experience; or MS degree with 3+ years of hands-on research experience.
  • Preferred: Experience in protein/peptide chemistry and characterization; ability to design and execute experiments, interpret and communicate results with minimal supervision.
  • Desirable: Experience with protein stability, structure or biophysical studies; hands-on experience with chromatography (SEC, IEX, RP, HIC) and biophysical techniques (DLS, MALS, SLS, AUC) for studying proteins.

Skills

  • Analytical and problem-solving skills
  • Strong communication (oral and written)
  • Team collaboration in fast-paced environment
  • Statistical analysis for study design and data interpretation

Education

  • BS or MS in Biochemistry, Chemistry, Biophysics, Protein Chemistry, Pharmaceutical Science, or related discipline (as specified in Qualifications).

Additional Requirements

  • Equal opportunity employer; background checks as part of recruitment process.