Associate Director, Immunoassay Critical Reagents and Reference Materials

Role: Associate Director, Immunoassay Critical Reagents and Reference Materials, leading strategic development of reagent systems for vaccine immunoassays. Responsibilities: oversee antibody reagent generation, characterization, qualification, stability, and lifecycle management; manage reference standards and custom assay materials; support immunoassay platform advancement; collaborate with cross-functional teams (Analytical Development, Quality, Manufacturing, Regulatory) and external vendors; ensure reagent supply continuity, performance, documentation, and regulatory compliance; lead stability studies, inventory systems, and technical troubleshooting; contribute to regulatory submissions and technical reports. Requirements: PhD in Biochemistry, Immunology, Analytical Chemistry, or related, with 7+ years (PhD) or 10+ years (MS) biopharma experience; deep expertise in antibody generation, assay reagent qualification, and lifecycle management; hands-on experience with immunoassay platforms (MSD, ELISA, multiplex); strong understanding of reagent stability, lot-to-lot comparability, and assay development; experience working with CROs, CDMOs, and external suppliers; GMP environment familiarity preferred. HighValue: vaccine immunoassays, critical reagent development, reference standard management, stability studies, lifecycle oversight, assay platform support, regulatory documentation, onsite in San Carlos, CA.