Overview In this on-site, lab-led leadership role, you will shape the immunoassay reagent and reference material strategy across Vaxcyte's vaccine pipeline. You'll manage generation, qualification, stability, and lifecycle of critical materials to ensure analytical reliability and regulatory readiness. You will collaborate with cross-functional teams and external partners to enable robust assays from development through lifecycle management. Your work will directly support assay quality, supply continuity, and program success in a fast-paced, mission-driven environment.
Compensation / Benefits- competitive compensation
- equity
- comprehensive benefits
- onsite work
Responsibilities- Establish and grow the Immunoassay Development Capability focused on reagents, reference materials, stability programs, and lifecycle management
- Lead hands-on laboratory activities for reagent planning, material readiness, study coordination, and data/documentation reviews
- Oversee generation, characterization, qualification, and inventory control of antibody reagents used in immunoassays
- Develop and execute antibody characterization plans (specificity, affinity, cross-reactivity, stability) and bridging strategies
- Manage reference materials (standards, calibrators, controls) and performance materials across assay workflows
- Design and implement stability studies and expiry/retest dating recommendations with clear data reporting
- Oversee customized immunoassay materials (plates, beads, reagents) and platform-specific components
- Coordinate with CROs/CDMOs and reagent vendors on scope, protocols, timelines, and data review
- Establish documentation best practices (qualification packages, CoAs, lot-release records, stability reports)
- Support method development, transfer, validation readiness, troubleshooting, and non-GMP/GMP testing as needed
- Lead investigations of performance trends using data-driven root-cause analysis
- Oversee outsourced activities related to reagent generation and material production
- Contribute to regulatory submissions and regulatory readiness for reagents and reference materials
- Represent Immunoassay Center of Excellence in cross-functional and vendor discussions
- Mentor scientists on reagent handling, stability, and lifecycle management
- Ensure daily laboratory operations, inventory planning, study scheduling, and data integrity
Key requirements- PhD with minimum 7 years of biopharmaceutical industry experience or MS with minimum 10 years"
- Extensive hands-on experience with antibody reagent generation, screening, characterization, qualification, conjugation, stabilization, and lifecycle management
- Proven track record managing immunoassay reagents, reference standards, assay controls, calibrators, and assay materials for ligand-binding assays or vaccine analytics
- Experience planning and running critical reagent/reference material stability studies and data interpretation
- Strong understanding of antibody-antigen interactions, specificity, affinity, cross-reactivity, and matrix effects
- Experience developing qualification strategies for critical reagents and reference materials
- Hands-on experience with immunoassay platforms (MSD, ELISA, electrochemiluminescence, Luminex, bead-based, multiplex)
- Experience with customized immunoassay materials (MSD plates, coated plates, labeled reagents, Luminex beads, kits, buffers)
- Experience supporting immunoassay method development, troubleshooting, transfer, validation readiness, and routine testing
- Background working in GMP-regulated analytical environments; familiarity with method qualification, validation, transfer, change control, deviations, CAPA
- Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or complex biologics is preferred
- Experience managing CROs/CDMOs/reagent vendors and external partners
- collaboration across cross-functional teams
- clear scientific communication
- data-driven problem solving
- antibody reagent generation, screening, and characterization
- reference material lifecycle management
- stability study design and analysis
