Sr Scientist I - Analytical Development, Biologics CMC

Role: Senior Scientist, Analytical Development for Biologics CMC, focusing on protein characterization and assay development for biologics, including ADCs, monoclonal antibodies, and bispecifics. Responsibilities: develop, optimize, qualify, and transfer LC-MS/MS and complementary analytical methods supporting pre-IND and clinical-stage biologics programs; support characterization of complex biologics attributes (e.g., PTMs, conjugation sites, DAR); oversee method transfer to external CDMOs/CTLs; review GMP and regulatory documentation; collaborate across R&D, manufacturing, QA, regulatory, and external partners; contribute to building internal lab capabilities. Requirements: Ph.D. in chemistry, biochemistry, or related field with relevant industry experience (preferred: 5+ years with Master's, 7+ with Bachelor's); deep expertise in high-resolution mass spectrometry (Orbitrap/Q-TOF), chromatography, electrophoresis, and assay development for ADCs and biologics; strong understanding of quality attributes, regulatory standards, and technical documentation. High-Value: biologics (monoclonal antibodies, bispecifics, ADCs), protein characterization, mass spectrometry, assay development, IND/clinical-stage programs, GMP compliance, cross-functional collaboration. Work Setup: laboratory-based, primarily in-office with limited travel.