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Lab Manager, Immunoassay Development, Critical Reagents & Reference Materials
Vaxcyte
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About this role
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.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*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.
Summary:
Vaxcyte is seeking an accomplished Lab Operations Manager, 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. In addition to critical reagent and reference standard responsibilities, this role will provide broad laboratory operations support for the overall CMC Immunoassay, including day-to-day lab coordination, equipment and consumable readiness, reagent and sample logistics, procurement support, vendor coordination, inventory systems, material tracking, laboratory organization, and operational planning. The role will be critical to enabling efficient, reliable, and well-controlled laboratory execution for immunoassay development, platform evaluation, routine testing, validation support, and control strategy activities. This is an onsite, laboratory-based role requiring daily engagement in laboratory operations, reagent and reference material planning, sample and material readiness, inventory tracking, study coordination, data review, documentation, procurement coordination, vendor follow-up, and hands-on technical support. The role will help establish and maintain practical laboratory systems that support high-quality scientific execution, supply continuity, data integrity, and operational excellence.
Experience supporting monoclonal antibody generation and characterization is required. Experience with antibody engineering is a plus. Experience helping set up or scale a laboratory, including equipment onboarding, consumable stocking, inventory systems, workflow organization, and operational readiness, is also a plus.
Essential Functions:
• Support daily operations for the CMC Immunoassay, including laboratory scheduling, reagent and consumable readiness, sample coordination, equipment availability, laboratory organization, study logistics, inventory tracking, documentation, and issue escalation.
• Support general laboratory management activities, including lab organization, space utilization, equipment tracking, instrument maintenance coordination, consumable stocking, safety readiness, sample flow, reagent flow, and day-to-day operational troubleshooting.
• Coordinate laboratory logistics across the CMC Immunoassay, including sample receipt, sample storage, reagent receipt, material aliquoting, labeling, chain of custody, shipment coordination, cold-chain handling, material transfers, and communication with internal and external stakeholders.
• Support procurement activities for the CMC Immunoassay, including identifying laboratory supply needs, coordinating purchase requests, tracking orders, following up with vendors, supporting new vendor setup, maintaining stock levels, and ensuring timely availability of reagents, consumables, equipment, and customized assay materials.
• Maintain inventory systems for critical reagents, reference standards, customized assay materials, consumables, laboratory supplies, and key assay components, including usage tracking, expiry or retest tracking, reserve stock monitoring, replenishment planning, and documentation.
• Support setup, organization, and operational readiness of the CMC Immunoassay laboratory, including equipment onboarding, reagent and consumable stocking, workflow setup, storage organization, inventory system implementation, and laboratory process improvement.
• Support antibody reagent generation, characterization, qualification, stability monitoring, and inventory management for capture antibodies, detection antibodies, monoclonal antibodies, polyclonal antibodies, labeled antibodies, and other assay-specific binding reagents.
• Support monoclonal antibody generation and characterization activities, including antigen preparation, screening support, clone tracking, purification support, conjugation or labeling support, specificity assessment, binding evaluation, and assay suitability testing.
• Support reference standard and assay control activities, including material preparation, aliquoting, labeling, storage, qualification-support testing, bridging-support testing, inventory control, stability tracking, and replenishment planning.
• Support customized immunoassay material management, including MSD plates, coated plates, labeled detection reagents, multiplex assay components, customized assay kits, buffers, blocking reagents, and other platform-specific critical materials.
• Coordinate critical reagent and reference material stability activities, including timepoint schedul
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