Scientist, Analytical Drug Product Development and Technology (DPDT) Full-time

Scientist

We are seeking a highly motivated Scientist to support the laboratory based analytical method development and qualification within the Drug Product Development and Technology (DPDT) group. The DPDT team supports all stages R&D work through commercial. You will be responsible for developing and qualifying analytical methods that will be assessing drug product stability of various drug products from pre-clinical to commercialization development.

A Typical Day in the Role Might Look Like:

• Support analytical strategy development 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.
• Prepare, author, and review critical analytical technical documents, including analytical method procedures (SOPs), method performance reports, method transfer documents and chip into pharmaceutical development reports for completeness and correctness.
• Guide and work with team members in conducting research and developmental activities. Investigates and solves problems related to the methods used to assess product quality and stability. Sets goals, assigns tasks, and provides performance management and development as needed.
• Maintain full working knowledge of analytical techniques and instruments and applies appropriately to projects and identify and assess novel analytical methods and technologies.
• Evaluate, interpret and present data at team meetings.
• Collaborate with other team members in DPDT and other functional groups at Regeneron in supporting the program development.
• Maintain accurate and complete laboratory record, participate in general lab instrument maintenance, and perform trouble shooting independently.

This Role Might Be For You If You Have:

• Enthusiasm in science with a motivation for making contributions in a team environment is necessary.
• Demonstrated communication skills, collaborative attitude and strong multi-tasking capabilities to thrive in matrix teams.
• Strong collaboration, teamwork, and communication skills.
• Independent, motivated, and detail-oriented with excellent problem-solving abilities.

This role requires a BS degree in Chemistry, Chemical Engineering, Biochemistry, or related field with ≥7 years of research experience, or MS degree in the above mentioned fields with ≥ 5-years of hands-on research experience. Familiarity with the quantitative and qualitative techniques used in peptide and/or biologic drug products, including capillary and microchip electrophoresis, HPLC/UPLC, mass spectrometry. Experience in biophysical characterization techniques such as DLS, HIAC, fluorescent labeling assays s is a plus. The ability to work independently to design experiments, as well as interpret, document and communicate results is required.