Senior Scientist, Immunoassay Development, Critical Reagents & Reference Materials

Vaxcyte•San Carlos, CA

12d•Onsite

About The Position

Vaxcyte is seeking an accomplished Senior Scientist, Immunoassay Critical Reagents and Reference Standards to join the CMC Immunoassay group. 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. The successful candidate will bring strong experience in monoclonal antibody generation and characterization, which is required for this role. Experience with antibody engineering is a plus. This role will partner closely with internal teams and external CROs, CDMOs, contract testing laboratories, reagent vendors, and technology partners to ensure reliable critical reagent and reference material supply, performance, documentation, and lifecycle management.

Requirements

PHD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline is preferred with a minimum of 5 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 10 years of relevant biopharmaceutical industry experience; or B.S. in a related discipline with a minimum of 13 years of relevant biopharmaceutical industry experience.
Hands-on experience with monoclonal antibody generation and characterization is required.
Significant experience with antibody reagent generation, screening, characterization, qualification, conjugation, labeling, lot bridging, stability assessment, and lifecycle management.
Experience managing or supporting immunoassay critical reagents, reference standards, assay controls, calibrators, and customized assay materials used in ligand-binding assays or vaccine analytical methods.
Experience planning, executing, and interpreting critical reagent and reference material stability studies, including protocol design, storage condition selection, timepoint testing, acceptance criteria, trend analysis, expiry or retest dating recommendations, and stability reporting.
Strong understanding of antibody-antigen interactions, assay reagent quality attributes, specificity, affinity, cross-reactivity, epitope behavior, matrix effects, reagent stability, and lot-to-lot comparability.
Hands-on experience with immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other ligand-binding assay technologies.
Experience with customized immunoassay materials such as MSD plates, coated plates, labeled detection reagents beads, multiplex panels, assay kits, buffers, and other platform-specific critical components.

Nice To Haves

Experience with antibody engineering is a plus.
Experience working in or supporting GMP-regulated analytical environments is desired.
Experience working with CROs, CDMOs, contract testing laboratories, reagent vendors, or external technology partners is desired.
Experience with antibody engineering, recombinant antibody production, hybridoma generation, antibody purification, antibody conjugation, biotinylation, ruthenium labeling, fluorescent labeling, bead conjugation, or multiplex panel design.
Direct experience supporting critical reagents or reference materials used for GMP release and stability testing.
Experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics.
Experience developing critical reagent control strategies, reagent history files, lifecycle management plans, stability protocols, bridging protocols, inventory control systems, and reagent replenishment strategies.

Responsibilities

Lead and execute laboratory studies supporting monoclonal antibody generation, screening, characterization, qualification, stability assessment, bridging, and lifecycle management.
Develop and execute characterization strategies for antibody reagents, including specificity, affinity, cross-reactivity, epitope behavior, assay performance, lot-to-lot comparability, stability, and suitability for intended immunoassay use.
Support antibody reagent generation strategies, including antigen design, immunization strategy, hybridoma or recombinant antibody generation, screening, clone selection, purification, conjugation, labeling, and long-term supply planning.
Lead and execute reference standard and assay control activities, including material selection, preparation, characterization, qualification, bridging, stability planning, lifecycle strategy, and inventory control.
Develop and execute stability plans for critical reagents and reference materials, 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.
Support customized immunoassay material generation and qualification, including MSD plates, coated plates, labeled detection reagents, multiplex assay components, customized assay kits, buffers, blocking reagents, and other platform-specific materials.
Establish qualification and bridging strategies for new critical reagent lots, reference material lots, and customized assay material lots to support assay continuity and data comparability.
Support inventory lifecycle management, including stock planning, usage forecasting, reserve strategy, storage conditions, chain of custody, expiry or retest dating, stability monitoring, documentation, and replenishment planning.
Contribute to regulatory-supporting documentation related to critical reagents, reference standards, stability programs, reagent qualification, comparability, and immunoassay control strategies.
Oversee outsourced activities related to monoclonal antibody generation, reagent manufacturing, reference material preparation, custom MSD plate production bead conjugation, customized kit generation, reagent characterization, stability studies, and critical material qualification.
Manage CRO, CDMO, contract testing laboratory, reagent vendor, and technology partner interactions, including technical scope definition, protocol review, study monitoring, data review, scientific problem-solving, timeline tracking, and deliverable acceptance.
Support immunoassay method development, troubleshooting, optimization, method 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.