Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences

Role: Senior Principal Scientist in Immunogenicity Bioanalytical Sciences at Amgen, focusing on assay design, validation, and implementation for detecting anti-drug antibodies in biologics development. Responsibilities: lead immunogenicity assay strategies across nonclinical and clinical programs, oversee transfer and validation to CROs, interpret complex data, ensure regulatory compliance, contribute to regulatory submissions, and mentor staff. Requirements: PhD in Biochemistry, Immunology, or related field with 3+ years industry experience, or equivalent with relevant GMP/GxP expertise. Preferred: extensive immunogenicity assay development and validation experience, knowledge of GLP/GCP, assay transfer, statistical analysis, and predictive immunogenicity methods; supervisory experience. High-Value: biologics (large molecules/proteins), immunogenicity (ADA/NAb detection), regulatory compliance, GLP/GCP, assay transfer to CROs, multidisciplinary collaboration. Work Setup: not specified, likely hybrid or on-site; no explicit travel details provided.