Sr. Associate Scientist, Drug Product Development and Technology (1 of 3)

Regeneron's Drug Product Development & Technology is seeking a Senior Associate Scientist as we work 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.

 

Job Duties:

 

• 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.

• Conduct pre-formulation studies for monoclonal antibodies, bioconjugates and peptides, using various biophysical and biochemical techniques to identify critical quality attributes for formulation and drug product development.

• Develop analytical methods for drug products, with primary focus on peptides, and supporting focus on antibody–drug conjugates, siRNA, monoclonal antibodies, and bispecific antibodies  

• Develop and qualify analytical methods for critical quality attributes to support formulation development, DP process development, and stability testing for programs in preclinical and clinical stage. 

• Characterize drug product 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 into 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.

 

Job Requirements:

 

• Take direction and guidance for data-driven decision making, priority setting and technical problem solving.

• Generate and organize data figures and data tables in a clear and insightful way

• Communicate critical data in timely manner to supervisor and team

• Strong ability to prioritize and manage multiple tasks effectively.

• Highly organized, detail-oriented, self-motivated, effective team player.

• Excellent oral and written communication skills.

This role requires a B.S or M.S degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or a related discipline with at least 3 years of industrial experience. The ability to design and execute experiments, as well as interpret, document, and communicate results with minimal supervision is required. 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.

$80,300.00 - $131,100.00