Associate Director, Immunoassay Development

Associate Director, Immunoassay Development

Vaxcyte is seeking an accomplished Associate Director, Immunoassay Development to join the Global Analytical Development organization. This role will provide scientific and strategic leadership for immunoassay development across Vaxcyte's vaccine pipeline, supporting platform evaluation and innovation, outsourcing and vendor oversight, method transfer, validation, lifecycle management, routine analytical testing, and immunoassay control strategy. This is an onsite, laboratory-based scientific leadership role with significant hands-on responsibilities and daily engagement in laboratory operations, experimental planning, assay execution, study oversight, data review, and technical support.

The Associate Director will lead and directly contribute to assay design, assay execution, data analysis, troubleshooting, method optimization, platform evaluation, method transfer support, validation readiness, and routine non-GMP or GMP-supporting analytical testing for complex conjugated vaccine programs and other vaccine pipeline assets. The successful candidate will bring strong technical expertise in immunoassay development for vaccines or biologics, with demonstrated experience developing, optimizing, troubleshooting, and lifecycle-supporting potency-, antigenicity-, identity-, and impurity-related immunoassays in CMC or regulated analytical environments.

A key responsibility of this role will be to strengthen Vaxcyte's hands-on immunoassay capability by developing new fit-for-purpose immunoassays, supporting platform evaluation and innovation, advancing assay robustness, and contributing to analytical control strategy across the vaccine pipeline.

The Associate Director will work closely with internal and external immunoassay subject matter experts, Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology, Regulatory, Program Management, CROs, CDMOs, contract testing laboratories, and technology partners to support method development, outsourcing, validation readiness, routine testing, GMP readiness, and long-term assay lifecycle strategy.

Essential Functions:

• Contribute to the establishment and growth of the Immunoassay Development Capability within the Global Analytical Development organization, with emphasis on hands-on immunoassay development, troubleshooting, method optimization, platform evaluation, routine testing, outsourcing support, validation readiness, and control strategy execution.
• Engage daily in laboratory operations, including experimental planning, assay execution, sample and reagent readiness, study scheduling, instrument and workflow coordination, data review, documentation, and hands-on technical support.
• Lead and directly execute laboratory studies for immunoassay development, optimization, troubleshooting, qualification support, method transfer, validation support, lifecycle management, and routine analytical testing.
• Provide hands-on technical leadership for immunoassays supporting potency, antigenicity, identity, impurity, characterization, comparability, release, and stability needs for complex conjugated vaccines and other vaccine pipeline programs.
• Design, execute, and interpret experiments to evaluate assay format, sample preparation, reagent strategy, plate or bead configuration, signal detection, curve behavior, recovery, precision, specificity, robustness, and system suitability.
• Independently troubleshoot immunoassay performance trends using structured, data-driven root-cause analysis approaches and clear experimental plans.
• Support development of new fit-for-purpose immunoassay methods from concept through optimization, qualification readiness, transfer readiness, validation readiness, and lifecycle strategy.
• Assess alternative and innovative immunoassay approaches, platforms, and formats to support assay modernization, multiplexing, throughput, sensitivity, specificity, robustness, and long-term control strategy.
• Support comparative evaluation of immunoassay technologies, including ELISA, MSD, Luminex, and other relevant ligand-binding assay formats.
• Perform and oversee routine analytical testing within the CoE, including development-stage testing, characterization testing, platform evaluation studies, method bridging, comparability support, reagent qualification, and other non-GMP or GMP-supporting analytical activities.
• Support outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, and external technology partners, including technical scope definition, study design review, data review, vendor communication, and deliverable tracking.
• Support immunoassay method validation activities in partnership with ASAT, QC, Quality, Regulatory, and external testing partners, including protocol input, acceptance criteria, data interpretation, deviation support, and final report review.
• Partner with internal and external subject matter experts to understand assay design, critical…