Associate Scientist, Formulation Development (DPDT)

Regeneron Pharmaceuticals•Tarrytown, GA

5d•$70,300 - $110,100•Onsite

About The Position

Regeneron's Drug Product Development and Technology Group is seeking an 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 may develop, qualify, and 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.

Requirements

B.S or MS degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or a related discipline with 0-3 years of hands-on laboratory experience.
The ability to design and execute experiments, as well as interpret, document, and communicate results with minimal supervision is required.

Nice To Haves

Relevant industry or intern experience is 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.

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.
Conduct biochemical and biophysical assessments and pre-formulation studies to support evaluation of preclinical drug candidates.
Characterize drug product (lyophilized or liquid) formulation to support process development and manufacturing of clinical drug substances and drug products.
Provide technical support for development, technology transfer and manufacture of drug substance and drug products and collaborate with cross-functional teams.
Develop and qualify analytical methods for critical quality attributes to support formulation development, drug product process development, and stability testing for programs in all development stages.
Document findings and lab records in electronic laboratory notebook by following the organizational best practices and policies.
Author protocols, technical documents for internal use and support regulatory filings.
Participate in meetings and present study results in department meetings or cross-functional team meetings.
Take part in the general laboratory and instrument maintenance.