Principal Scientist, Project Toxicologist

Role: Senior Principal Scientist leading immunogenicity bioanalytical assay development for large molecule therapeutics at Amgen, supporting GLP preclinical and regulated clinical studies. Responsibilities: design, develop, validate, transfer, and implement assays for anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs); provide scientific leadership in assay strategy, troubleshooting, and data interpretation; oversee assay transfer to CROs, ensure compliance with regulatory standards, and contribute to regulatory documentation. Requirements: PhD in Biochemistry, Immunology, or related field with 3+ years industry experience, or equivalent with relevant expertise in immunogenicity assays; strong knowledge of GLP/GCP, global regulatory guidelines, and statistical validation; experience with cell-based and drug-tolerant immunogenicity assays; supervisory skills preferred. HighValue: expertise in ADA/NAb assay development, validation, and transfer per global standards; familiarity with predictive immunogenicity methods; experience in a matrixed environment supporting preclinical and clinical stages; ability to lead cross-functional teams and mentor staff. WorkSetup: not specified, but implies collaboration across research, development, and CROs.