Vaxcyte

Vaxcyte

Associate Director, Immunoassay Development

San Carlos, California, United States · Director

Sponsorship not specifiedDetected 41 days ago
Data AnalysisGMPFDA RegulatoryExperimental DesignProtein AnalysisLeadershipCommunicationCollaboration

About the role

  • 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.

Responsibilities

  • 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.
  • Lead and directly execute laboratory studies for immunoassay development, optimization, troubleshooting, qualification support, method transfer, validation support, lifecycle management, and routine analytical testing.
  • 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.

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.
  • Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, Luminex, or other relevant immunoassay technologies.
  • Proven ability to troubleshoot complex immunoassay performance trends using structured, data-driven root-cause analysis approaches.
  • Experience evaluating alternative or innovative immunoassay platforms and translating experimental data into method development recommendations.
  • Hands-on experience with MSD platforms is highly desirable.
  • Working knowledge of global regulatory expectations for analytical methods supporting vaccines and biologics, including FDA, EMA, ICH, and GMP expectations.
  • Demonstrated ability to mentor, train, and provide technical guidance to laboratory scientists.
  • Strong scientific judgment and the ability to make sound technical recommendations when working with incomplete, complex, or conflicting data.

Nice to have

  • Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.
  • Hands-on experience with Luminex or other multiplex immunoassay platforms is a plus.

Company info

  • Join our Mission to Protect Humankind!
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This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.