Process Development Senior Scientist - Attribute Sciences

Role: Senior Scientist in Process Development - Attribute Sciences at Amgen, focusing on biologics. Responsibilities: develop, optimize, troubleshoot, and validate analytical methods for monitoring critical quality attributes; lead late-stage protein characterization, using high-resolution LC/MS, including peptide and disulfide mapping, and intact mass analysis; establish automated, efficient workflows; interpret complex data and author/regulatory documentation for INDs and BLAs; provide technical guidance to cross-functional teams. Requirements: PhD or Master’s with 2+ years, or Bachelor’s with 4+ years of scientific experience; expertise in analytical method development, structural and physicochemical characterization of biologics (monoclonal antibodies, fusion proteins, ADCs); hands-on experience with LC/MS (Orbitrap preferred), sample preparation, and automation; experience with regulatory submissions. Preferred: >3 years in pharmaceutical process support, deep LC/MS expertise, laboratory automation skills, and experience with regulatory CTDs. HighValue: biologics, monoclonal antibodies, ADCs; late-stage development, IND/BLA submissions, analytical support, GxP compliance. Collaboration: cross-functional teams including process development, QC, regulatory. Location: Cambridge, MA, with no specified travel.