Associate Director, Immunoassay Critical Reagents and Reference Materials

Summary:

Vaxcyte is seeking an accomplished Associate Director, Immunoassay Critical Reagents and Reference Materials to join the Global Analytical Development organization. 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.

This is an onsite, laboratory-based scientific leadership position requiring active engagement in laboratory operations, study oversight, inventory management, data review, and technical decision-making. The successful candidate will bring deep expertise in antibody generation and characterization, reagent qualification, reference standard development, customized assay material management, stability assessment, and lifecycle strategy.

A key focus of this role will be establishing and maintaining robust reagent and reference material systems that ensure long-term supply continuity, analytical reliability, and regulatory readiness. The individual will support immunoassay platform advancement and enable fit-for-purpose assays throughout development, validation, commercialization, and lifecycle management.

The Associate Director will collaborate closely with cross-functional teams, including Analytical Development, Quality, Manufacturing, Regulatory Affairs, and Supply Chain, as well as external partners such as CROs, CDMOs, contract testing laboratories, reagent suppliers, and technology providers. This role is responsible for ensuring the consistent availability, performance, documentation, and oversight of critical immunoassay materials while driving continuous improvement and operational excellence across the portfolio.

Essential Functions:

• Contribute to the establishment and growth of the Immunoassay Development Capability within Global Analytical Development organization, with primary responsibility for immunoassay critical reagents, reference materials, customized assay materials, stability programs, and associated lifecycle management systems.
• Engage daily in laboratory operations, including reagent planning, reference material planning, sample and material readiness, laboratory study coordination, inventory review, data review, documentation, and hands-on technical support.
• Lead the generation, characterization, qualification, stability planning, lifecycle management, and inventory control of antibody reagents used in immunoassays, including capture antibodies, detection antibodies, monoclonal antibodies, polyclonal antibodies, labeled antibodies, and other assay-specific binding reagents.
• Support antibody reagent generation strategies, including antigen design, immunization strategy, hybridoma or recombinant antibody generation, screening, clone selection, purification, conjugation, labeling, characterization, and long-term supply planning.
• Develop and execute antibody characterization plans, including specificity, affinity, cross-reactivity, epitope behavior, lot-to-lot comparability, assay performance attributes, stability, and suitability for intended immunoassay use.
• Lead the generation, characterization, qualification, bridging, stability planning, lifecycle management, and inventory control of reference materials, including reference standards, assay controls, calibrators, system suitability controls, bridging controls, and other assay performance control materials.
• Design and execute critical reagent and reference material stability studies, 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.
• Lead the generation, characterization, qualification, and lifecycle management of customized immunoassay critical materials, including MSD plates, coated plates, Sulfo-TAG or other labeled detection reagents, bead-conjugated reagents, multiplex assay components, customized assay kits, buffers, blocking reagents, and other platform-specific critical materials.
• 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.
• Establish and maintain critical reagent and reference material inventory systems, including stock planning, usage forecasting, storage conditions, chain of custody, expiry or retest dating, reserve strategy, stability monitoring, documentation, and replenishment planning.
• Partner with immunoassay development scientists to understand method-specific reagent requirements, assay design, critical material attributes, platform considerations, assay controls, and long-term control strategy needs.
• Support immunoassay method development, optimization, troubleshooting, 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.
• Lead or support investigations of reagent or reference material performance trends using structured, data-driven root-cause analysis approaches and clear experimental plans.
• Oversee outsourced activities related to antibody generation, reagent manufacturing, reference material preparation, custom MSD plate production, customized kit generation, reagent characterization, stability studies, and critical material qualification.
• Manage CRO, CDMO, contract testing laboratory, reagent vendor, and technology partner relationships, including technical scope definition, vendor selection support, statement of work input, protocol review, study monitoring, data review, scientific/technical problem-solving, timeline tracking, and deliverable acceptance.
• Review and approve, as appropriate, external study plans, protocols, batch records, certificates of analysis, characterization reports, qualification reports, stability data, inventory records, and technical summaries related to critical reagents and reference materials.
• Establish best practices for critical reagent documentation, including reagent history files, qualification packages, characterization reports, stability protocols and reports, inventory records, usage logs, CoAs, lot-release records, bridging reports, and lifecycle management plans.
• Support ASAT, QC, Quality, Regulatory, and external testing partners in method transfer, validation support, change control, deviation investigation, CAPA, reagent replenishment, reference material replenishment, and long-term assay lifecycle management.
• Contribute to regulatory submissions, health authority responses, technical reports, method development reports, validation strategies, comparability packages, and BLA-supporting documentation related to critical reagents, reference materials, stability programs, and immunoassay control strategies.
• Represent the CMC Immunoassay group  cross-functional project teams, technical reviews, vendor meetings, external collaborations, and governance forums as needed.
• Mentor and provide technical guidance to laboratory scientists on reagent handling, reference material handling, characterization methods, stability study execution, qualification studies, troubleshooting, documentation, and good laboratory practices.

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.
• Demonstrated experience managing 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.
• Experience developing and executing qualification strategies for critical reagents and reference materials, including acceptance criteria, bridging approaches, stability monitoring, lifecycle planning, and replenishment planning.
• Hands-on experience with immunoassay platforms such as MSD, ELISA, electrochemiluminescence-based assays, multiplex assays, or other ligand-binding assay technologies.
• Experience with customized immunoassay materials such as MSD plates, coated plates, labeled detection reagents, 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.
• Experience working with CROs, CDMOs, contract testing laboratories, reagent vendors, or external technology partners is desired.
• Demonstrated ability to oversee outsourced reagent generation, characterization, qualification, stability, custom assay material production, or testing activities.
• Demonstrated ability to support daily laboratory operations, including reagent and reference material planning, study scheduling, inventory management, data review, documentation, and technical support.
• Experience working in or supporting GMP-regulated analytical environments is desired, including familiarity with method qualification, validation, transfer, change control, deviations, investigations, CAPA, data integrity, critical reagent control, and lifecycle management.
• Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.
• Solid understanding of protein chemistry, polysaccharide chemistry, conjugation chemistry, antibody engineering or production, reagent conjugation, and biological sample matrix effects as applied to vaccine analytical development.
• Strong organizational skills with demonstrated experience managing reagent inventories, reference material inventories, documentation systems, stability schedules, external deliverables, timelines, and cross-functional priorities.
• Strong scientific judgment and the ability to make sound technical recommendations when working with incomplete, complex, or conflicting data.
• Excellent written and verbal communication skills, with the ability to clearly communicate technical concepts, study results, risks, and recommendations to cross-functional stakeholders, external partners, and regulatory audiences.
• Strong commitment to data integrity, documentation quality, scientific excellence, accountability, supply continuity, and continuous improvement.

Preferred Qualifications: 

• Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial launch, or lifecycle management of vaccine or biologics programs.
• Direct experience supporting critical reagents or reference materials used for GMP release and stability testing.
• Experience with antibody discovery, hybridoma generation, recombinant antibody production, antibody purification, antibody conjugation, biotinylation, ruthenium labeling, fluorescent labeling, or bead conjugation.
• Hands-on experience with MSD platforms, including custom plate coating, labeled detection reagents, and assay reagent qualification.
• Hands-on experience with Luminex or other multiplex immunoassay platforms, including bead coupling, bead characterization, multiplex panel design, and lot bridging.
• Experience managing outsourced antibody generation, reagent manufacturing, reference material preparation, customized assay kit production, stability studies, or critical reagent qualification with CROs, CDMOs, or reagent vendors.
• Experience developing critical reagent control strategies, reagent history files, lifecycle management plans, stability protocols, bridging protocols, inventory control systems, and reagent replenishment strategies.
• Experience contributing to health authority responses or regulatory submissions on analytical methods, critical reagents, reference standards, stability programs, potency assays, antigenicity assays, or immunoassay control strategies.
• Experience helping build or scale analytical capabilities, critical reagent programs, or laboratory teams within a growing organization.
• Experience with multivalent or highly complex vaccine programs.
• Experience with automation, high-throughput reagent characterization workflows, electronic inventory systems, LIMS, ELN, and digital data analysis tools.