Vaxcyte
Associate Director, Immunoassay Critical Reagents and Reference Materials
San Carlos, California, United States · Director
Sponsorship not specifiedDetected 20 hours ago
ForecastingSupply ChainInventory ManagementGMPFDA RegulatoryProtein AnalysisLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- 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.
Responsibilities
- 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.
Requirements
- 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.
- 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 MSD, ELISA, electrochemiluminescence-based assays, Luminex, 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, Luminex beads, multiplex panels, assay kits, buffers, and other platform-specific critical components.
- Experience supporting immunoassay method development, troubleshooting, optimization, method transfer, validation readiness, platform evaluation, or routine analytical testing.
- Proven ability to troubleshoot reagent- or reference material-related performance trends using structured, data-driven root-cause analysis approaches.
Company info
- Join our Mission to Protect Humankind!
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