Hiring: Associate Director, Immunoassay Critical Reagents and Reference Materials Company: Vaxcyte Location: San Carlos, CA Job Posted Time: 2026-09-10 10:36:35 Employment Type: Contract About the job Experience: •7 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 10 years of relevant biopharmaceutical industry experience. Required Skills: •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. •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. Qualifications: •PhD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 7 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 10 years of relevant biopharmaceutical industry experience. •Significant hands-on experience with antibody reagent generation, screening, characterization, qualification, conjugation, labeling, lot bridging, stability assessment, and lifecycle management. •Demonstrated experience managing immunoassay critical reagents, reference standards, assay controls, calibrators, and customized assay materials used in ligand-binding assays or vaccine analytical methods. •In-depth knowledge of antibody-antigen interactions, assay reagent quality attributes, specificity, affinity, cross-reactivity, epitope behavior, matrix effects, reagent stability, and lot-to-lot comparability. •Applied hands-on capability in immunoassay platforms such as MSD, ELISA, electrochemiluminescence-based assays, multiplex assays, or other ligand-binding assay technologies. •Proven ability to troubleshoot reagent- or reference material-related performance trends using structured, data-driven root-cause analysis approaches. •Demonstrated ability to oversee outsourced reagent generation, characterization, qualification, stability, custom assay material production, or testing activities. •Demonstrated ability to support daily laboratory operations, including reagent and reference material planning, study scheduling, inventory management, data review, documentation, and technical support. •Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred. Compensation: •$190,000 - $220,000 / year •Competitive benefits and rewards package •The compensation package will be competitive and includes comprehensive benefits and an equity component Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!