Lab Manager, Immunoassay Development

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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 scheduling, sample pull coordination, testing readiness, data tracking, trend documentation, inventory impact assessment, and report support.
• Maintain accurate and inspection-ready documentation for critical reagents, reference materials, customized assay materials, certificates of analysis, lot history records, usage logs, stability records, procurement records, inventory records, and qualification documentation.
• Perform hands-on laboratory testing to support reagent characterization, reference material characterization, lot comparison, stability studies, qualification support, bridging support, method development, platform evaluation, and routine analytical testing.
• Support CRO, CDMO, contract testing laboratory, reagent vendor, and technology partner activities, including material shipment coordination, purchase order tracking, study tracking, communication support, data receipt, documentation review, deliverable tracking, and timeline follow-up.
• Support immunoassay development, optimization, troubleshooting, platform evaluation, method transfer, validation readiness, and routine testing as needed, especially when reagent or reference material performance, material readiness, or laboratory logistics are central to assay execution.
• Work closely with scientists, senior scientists, Associate Directors, and the Director to support laboratory planning, reagent planning, procurement planning, study scheduling, inventory review, and cross-functional project needs.
• Contribute to laboratory process improvements, including inventory workflows, reagent request processes, sample tracking processes, procurement workflows, equipment readiness tracking, documentation templates, and laboratory organization standards.
• Support good laboratory practices, safety expectations, data integrity, documentation quality, and operational discipline across the CMC Immunoassay.

Requirements: 

• MS. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 3 years of relevant biopharmaceutical industry laboratory experience; or B.S. in a related discipline with a minimum of 5 years of relevant biopharmaceutical industry laboratory experience. Other combinations of education and/or experience may be considered.
• Hands-on experience supporting monoclonal antibody generation, screening, characterization, qualification, conjugation, labeling, or lifecycle management is required.
• Experience supporting critical reagent, reference standard, assay control, calibrator, or customized assay material management for immunoassays or ligand-binding assays.
• Experience supporting general laboratory operations, including reagent and consumable planning, sample logistics, inventory management, equipment coordination, laboratory organization, documentation, and daily operational support.
• Experience supporting procurement or supply coordination for laboratory operations, including purchase request support, order tracking, vendor communication, stock monitoring, and consumable replenishment.
• Experience supporting reagent or reference material stability studies, including timepoint tracking, sample pull coordination, testing support, data tracking, trend monitoring, and documentation.
• Experience with immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other ligand-binding assay technologies.
• Strong organizational skills and attention to detail, with experience managing inventories, sample tracking, reagent records, procurement records, documentation systems, and laboratory schedules.
• Ability to coordinate multiple laboratory priorities, material needs, testing schedules, procurement timelines, vendor interactions, and documentation deliverables in a fast-paced environment.
• Experience supporting outsourced reagent generation, characterization, qualification, stability, custom assay material production, or testing activities with CROs, CDMOs, contract testing laboratories, reagent vendors, or technology partners is desired.
• Experience working in or supporting GMP-regulated analytical environments is desired.
• Strong written and verbal communication skills, with the ability to clearly communicate material status, inventory risks, study logistics, procurement needs, technical observations, and operational priorities.
• Strong commitment to laboratory safety, data integrity, documentation quality, scientific excellence, accountability, supply continuity, and continuous improvement.

Preferred Qualifications:

• Experience helping establish, organize, or scale a laboratory, including equipment onboarding, consumable stocking, reagent storage setup, inventory system implementation, workflow organization, and operational readiness.
• Experience with antibody engineering, recombinant antibody production, hybridoma workflows, antibody purification, antibody conjugation, biotinylation, ruthenium labeling, fluorescent labeling, or bead conjugation.
• Experience with MSD custom plates, labeled detection reagents, multiplex panel materials, or customized assay kits.
• Experience supporting critical reagent control strategies, reagent history files, lifecycle management plans, stability protocols, bridging protocols, inventory control systems, and reagent replenishment strategies.
• Experience with laboratory procurement systems, vendor onboarding, purchase order tracking, electronic inventory systems, LIMS, ELN, and digital data analysis tools.
• Experience supporting vaccine, biologics, conjugated vaccine, multivalent vaccine, or complex analytical development programs.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.