JobMesh

Scientist, Analytical Drug Product Development and Technology (DPDT)

Regeneron · Tarrytown, New York, US

We are seeking a highly motivated Scientist to support the laboratory based analytical method development and qualification within the Drug Product Developme...

Job description

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 res...