Process Development Sr Scientist

Role: Process Development Senior Scientist within Amgen’s Attribute Sciences department, focusing on biologic therapeutics such as monoclonal antibodies, bispecifics, and ADCs. Responsibilities: lead analytical support for late-stage product development, define analytical target profiles, oversee method development, qualification, transfer, and remediation; manage activities at contract testing sites; author technical and regulatory documentation; drive product characterization supporting process comparability and regulatory filings; provide strategic analytical leadership; collaborate closely with Drug Substance and Drug Product teams. Qualifications: PhD, PharmD, or MD with relevant post-doc, or a master’s with 3+ years or bachelor’s with 5+ years of scientific experience; strong background in analytical chemistry, biochemistry, or related fields; proficiency in mass spectrometry, HPLC, CE methods; knowledge of regulatory standards and biologic quality attributes; experience in method development, validation, transfer, and GMP compliance; excellent communication and cross-functional leadership skills; experience with biologics including antibodies and fusion proteins preferred. HighValue: biologics, monoclonal antibodies, ADCs, bispecifics; analytical method development, regulatory documentation, process characterization, GLP/GMP compliance, late-stage clinical support. Worksetup: based at Thousand Oaks, CA; role may involve cross-site coordination.