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

About the role

Regeneron's Drug Product Development & Technology 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. This role involves applying biochemical and biophysical methods to conduct developability assessments and formulation development studies on monoclonal antibody-based therapeutics.

Responsibilities

• 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.
• 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 a 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.

Requirements

• Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or a related discipline.
• At least 3 years of industrial experience.
• Ability to design and execute experiments, as well as interpret, document, and communicate results with minimal supervision.
• Strong technical knowledge base and relevant experience with protein/peptide chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development and biomolecule product development.
• 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).

Qualifications

• Experience with monoclonal antibody-based therapeutics and drug product development.
• Knowledge of biophysical and biochemical techniques for protein characterization.
• Experience with analytical methods for drug products, particularly peptides.
• Understanding of formulation development and stability testing for preclinical and clinical programs.
• Ability to contribute to technical reports and regulatory filings.

Skills

• Strong ability to prioritize and manage multiple tasks effectively.
• Highly organized, detail-oriented, self-motivated, effective team player.
• Excellent oral and written communication skills.

Benefits

Regeneron offers comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

Pay

$80,300.00 - $131,100.00 annually

Schedule

Full time