Senior Scientist, Immunoassay Development, Critical Reagents & 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.

• 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.

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.

• 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…