Associate Director, Immunoassay Development

About the role

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 r

Benefits

Additional Information

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.

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