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Vaxcyte, a clinical-stage vaccine innovation company, is seeking a Senior Scientist to lead the development and lifecycle management of critical reagents and reference materials for immunoassays supporting its vaccine pipeline. The role sits within the CMC (Chemistry, Manufacturing, and Controls) Immunoassay Group and requires deep expertise in monoclonal antibody generation, characterization, and qualification.
Key responsibilities include:
• Lead laboratory studies for monoclonal antibody generation, screening, characterization, qualification, stability assessment, and lifecycle management.
• Develop comprehensive characterization strategies for antibody reagents, assessing specificity, affinity, cross-reactivity, epitope behavior, assay performance, lot-to-lot comparability, and stability.
• Support antibody reagent generation strategies, including antigen design, immunization approaches, hybridoma or recombinant antibody generation, clone selection, purification, conjugation, and labeling.
• Lead reference standard and assay control activities, including material selection, preparation, characterization, qualification, bridging, and lifecycle strategy.
• Develop and execute stability plans for critical reagents and reference materials, including protocol development, storage condition assessment, testing strategy, acceptance criteria, and expiry recommendations.
• Support customized immunoassay material generation and qualification for platforms such as MSD, Luminex, and multiplex assay systems.
• Establish qualification and bridging strategies for new critical reagent lots to ensure assay continuity and data comparability.
• Manage inventory lifecycle, including stock planning, usage forecasting, reserve strategy, storage conditions, and replenishment planning.
• Contribute to regulatory-supporting documentation related to critical reagents, stability programs, and immunoassay control strategies.
• Oversee outsourced activities with CROs, CDMOs, contract testing laboratories, reagent vendors, and technology partners, including technical scope definition, protocol review, study monitoring, and data review.
• Support immunoassay method development, troubleshooting, optimization, and validation readiness as needed.
The ideal candidate brings strong experience in monoclonal antibody generation and characterization, with antibody engineering experience as a plus. This role requires close collaboration with internal teams and external partners to ensure reliable critical reagent and reference material supply, performance, documentation, and lifecycle management.
