Associate Director, Immunoassay Critical Reagents and Reference Materials

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.Summary: Vaxcyte is seeking an accomplished Associate Director, Immunoassay Critical Reagents and Reference Materials to join the Global Analytical Development organization. This role will provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline. This is an onsite, laboratory-based scientific leadership position requiring active engagement in laboratory operations, study oversight, inventory management, data review, and technical decision-making. 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 of this role will be establishing and maintaining robust reagent and reference material systems that ensure long-term supply continuity, analytical reliability, and regulatory readiness. The individual will support immunoassay platform advancement and enable fit-for-purpose assays throughout development, validation, commercialization, and lifecycle management. The Associate Director will collaborate closely with cross-functional teams, including Analytical Development, Quality, Manufacturing, Regulatory Affairs, and Supply Chain, as well as external partners such as CROs, CDMOs, contract testing laboratories, reagent suppliers, and technology providers. This role is responsible for ensuring the consistent availability, performance, documentation, and oversight of critical immunoassay materials while driving continuous improvement and operational excellence across the portfolio. Essential Functions: Contribute to the establishment and growth of the Immunoassay Development Capability within Global Analytical Development organization, with primary responsibility for immunoassay critical reagents, reference materials, customized assay materials, stability programs, and associated lifecycle management systems. Engage daily in laboratory operations, including reagent planning, reference material planning, sample and material readiness, laboratory 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, including capture antibodies, detection antibodies, monoclonal antibodies, polyclonal antibodies, labeled antibodies, and other assay-specific binding reagents. Support antibody reagent generation strategies, including antigen design, immunization strategy, hybridoma or recombinant antibody generation, screening, clone selection, purification, conjugation, labeling, characterization, and long-term supply planning. Develop and execute antibody characterization plans, including specificity, affinity, cross-reactivity, epitope behavior, lot-to-lot comparability, assay performance attributes, stability, and suitability for intended immunoassay use. Lead the generation, characterization, qualification, bridging, stability planning, lifecycle management, and inventory control of reference materials, including reference standards, assay controls, calibrators, system suitability controls, bridging controls, and other assay performance control materials. Design and execute critical reagent and reference material stability studies, including protocol development, storage condition assessment, timepoint planning, testing strategy, acceptance criteria, data interpretation, trend evaluation, expiry or retest dating recommendations, and stability report generation. Lead the generation, characterization, qualification, and lifecycle management of customized immunoassay critical materials, including MSD plates, coated plates, Sulfo-TAG or other labeled detection reagents, Luminex beads, bead-conjugated reagents, multiplex assay components, customized assay kits, buffers, blocking reagents, and other platform-specific critical materials. Develop qualification and bridging strategies for new critical reagent lots, reference material lots, and customized assay material lots to support continuity of assay performance and data comparability. Establish and maintain critical reagent and reference material inventory systems, including stock planning, usage forecasting, storage conditions, chain of custody, expiry or retest dating, reserve strategy, stability monitoring, documentation, and replenishment planning. Partner with immunoassay development scientists to understand method-specific reagent requirements, assay design, critical material attributes, platform considerations, assay controls, and long-term control strategy needs. Support immunoassay method development, optimization, troubleshooting, transfer, validation readiness, and routine analytical testing as needed, particularly when reagent quality, reference material performance, stability, or customized critical material attributes are central to assay execution. Provide hands-on laboratory support for reagent characterization, reference material characterization, stability studies, assay qualification studies, bridging studies, comparability assessments, platform evaluation studies, and routine non-GMP or GMP-supporting analytical testing. Lead or support investigations of reagent or reference material performance trends using structured, data-driven root-cause analysis approaches and clear experimental plans. Oversee outsourced activities related to antibody generation, reagent manufacturing, reference material preparation, custom MSD plate production, Luminex bead conjugation, customized kit generation, reagent characterization, stability studies, and critical material qualification. Manage CRO, CDMO, contract testing laboratory, reagent vendor, and technology partner relationships, including technical scope definition, vendor selection support, statement of work input, protocol review, study monitoring, data review, scientific/technical problem-solving, timeline tracking, and deliverable acceptance. Review and approve, as appropriate, external study plans, protocols, batch records, certificates of analysis, characterization reports, qualification reports, stability data, inventory records, and technical summaries related to critical reagents and reference materials. Establish best practices for critical reagent documentation, including reagent history files, qualification packages, characterization reports, stability protocols and reports, inventor