Associate Director, Immunoassay Critical Reagents and Reference Materials

Job title: Associate Director, Immunoassay Critical Reagents and Reference Materials

About the Role Vaxcyte is seeking an accomplished Associate Director, Immunoassay Critical Reagents and Reference Materials to join the Global Analytical Development organization. This onsite, laboratory-based leadership role provides scientific and strategic oversight for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline. The successful candidate will bring deep expertise in antibody generation and characterization, reagent qualification, reference standard development, customized assay material management, stability assessment, and lifecycle strategy. A key focus is establishing robust reagent and reference material systems to ensure long-term supply continuity, analytical reliability, and regulatory readiness. The Associate Director will enable fit-for-purpose assays throughout development, validation, commercialization, and lifecycle management, collaborating with cross-functional teams and external partners. The role requires active engagement in laboratory operations, study oversight, inventory management, data review, and technical decision-making.

What You'll Do

• Contribute to the establishment and growth of the Immunoassay Development Capability within Global Analytical Development, with primary responsibility for immunoassay critical reagents, reference materials, customized assay materials, stability programs, and lifecycle management systems.
• Engage daily in laboratory operations: reagent planning, reference material planning, sample and material readiness, study coordination, inventory review, data review, documentation, and hands-on technical support.
• Lead the generation, characterization, qualification, stability planning, lifecycle management, and inventory control of antibody reagents used in immunoassays (capture/detection antibodies, monoclonal/polyclonal, labeled antibodies, and other assay-specific binders).
• Support antibody reagent generation strategies (antigen design, immunization strategy, hybridoma or recombinant generation, screening, clone selection, purification, conjugation, labeling, characterization, and long-term supply planning).
• Develop and execute antibody characterization plans (specificity, affinity, cross-reactivity, epitope behavior, lot-to-lot comparability, assay performance attributes, stability, and suitability).
• Lead the generation, characterization, qualification, stability planning, lifecycle management, and inventory control of reference materials (reference standards, assay controls, calibrators, system suitability, bridging controls, and other assay performance materials).
• Design and execute critical reagent and reference material stability studies (protocol development, storage condition assessment, timepoints, testing strategy, acceptance criteria, data interpretation, trend evaluation, expiry dating recommendations, and stability report generation).
• Lead the generation, characterization, qualification, and lifecycle management of customized immunoassay critical materials (MSD plates, coated plates, detection reagents, Luminex beads, multiplex components, assay kits, buffers, blocking reagents, and platform-specific materials).
• Develop qualification and bridging strategies for new reagent lots and reference material lots to support assay performance and data comparability.
• Establish and maintain critical reagent and reference material inventory systems (stock planning, usage forecasting, storage, chain of custody, expiry dating, reserve strategy, stability monitoring, documentation, and replenishment planning).
• Partner with immunoassay development scientists to understand method-specific reagent requirements, assay data needs, and collaboration with external partners such as CROs, CDMOs, contract testing laboratories, reagent suppliers, and technology providers.

This role will collaborate closely with cross-functional teams (Analytical Development, Quality, Manufacturing, Regulatory Affairs, and Supply Chain) to ensure consistent availability, performance, documentation, and governance of immunoassay materials, while driving continuous improvement and operational excellence across the portfolio.