Sr Associate Scientist, Formulation Development

Role Summary

Regeneron's Formulation Development Group is seeking a Senior Associate Scientist to support all stages of pre-clinical, clinical, commercial formulation, and drug product development for various drug product modalities. In this role, you will 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 the candidates of monoclonal antibodies, bioconjugates and peptides, using various biophysical and biochemical techniques to identify critical quality attributes for formulation and drug product development.
• Design and independently execute phase-appropriate formulation development studies, such as formulation screening, stability and compatibility studies, to support drug product development for early and late-stage development programs.
• Characterize the drug product (lyophilized or liquid) formulation to support the process development and manufacturing of clinical drug substances and drug products.
• Document findings and lab records in electronic laboratory notebook by following the 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 team meetings or department meetings.
• Author protocols, technical documents for internal use and support regulatory filings.
• Take part in the general laboratory and instrument maintenance.

Qualifications

• BS with 4+ years or MS with a minimum of 2 years of relevant post-degree laboratory experience in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or a related discipline. Relevant industry experience preferred.
• Strong technical knowledge base and relevant experience with protein/peptide chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development and biomolecule product development is desirable.
• 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 data
• Strong prioritization and multitasking abilities
• Detail-oriented, self-motivated, effective team player
• Excellent oral and written communication skills

Additional Requirements

• Equal opportunity employer information and background checks as part of the recruitment process may apply (content omitted for brevity in description).