Bioanalytical Portfolio Scientist

Role: Bioanalytical Portfolio Scientist responsible for scientific oversight of outsourced immunogenicity bioanalytical methods, including ADA and NAb assays, ensuring validation, performance, and regulatory compliance. Responsibilities: transfer, validation, and monitoring of assays at CROs; ensure data integrity; collaborate internally and externally; support regulatory activities; manage method lifecycle and troubleshooting. Requirements: PhD or Master’s with 2+ years, or Bachelor’s with 4+ years in regulated bioanalytical labs; expertise in immunoassay development, validation, and troubleshooting; experience working with CROs. Preferred: knowledge of current regulatory expectations, project and people management, strong communication, and collaboration skills. HighValue: focus on immunogenicity assays (ADA/NAb), GLP/GCP compliance, external vendor oversight, and assay lifecycle management. The role supports Amgen’s focus on Oncology, Inflammation, Rare Disease, and General Medicine, working within a scientific, collaborative environment. Location: Not specified; likely hybrid or remote based on typical roles.