Associate Director, Analytical Development (Bioassay)

Role: Associate Director, Analytical Development (Bioassay) at Insmed, leads bioassay method development, validation, and troubleshooting for biologic therapeutics, with a focus on potency and impurity assays. Responsibilities include designing assays using platforms like ELISA, SPR, BLI, MSD, supporting biologics across early to late development stages, managing CROs and CDMOs, authoring regulatory submissions (IND, IMPD, BLA), and ensuring compliance with GMP and global regulatory standards. The role involves scientific leadership, cross-functional collaboration with R&D and CMC teams, and mentoring a team of scientists. Qualifications: Ph.D. in Biochemistry, Molecular Biology, or related field with 3+ years (Ph.D.) or 7+ years (M.S.) industry experience in bioassay development and biologics characterization, with proven leadership and regulatory expertise. High-value: biologics (monoclonal antibodies, fusion proteins, enzymes), biologics development, GMP, regulatory submissions, and external partner management. Work location: Bridgewater, NJ, in-person; minimal travel.