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Vaxcyte, a clinical-stage vaccine innovation company, is seeking a Director of Immunoassay Development to lead the CMC (Chemistry, Manufacturing, and Controls) Immunoassay group. This hands-on scientific leadership role focuses on developing, qualifying, and managing critical immunoassays that support vaccine development, manufacturing, and commercialization across Vaxcyte's pipeline.
Key responsibilities include establishing and scaling the immunoassay capability within CMC, defining operating models, technical standards, platform strategy, and outsourcing approaches. The director will provide daily laboratory leadership, including experimental planning, schedule coordination, study prioritization, data review, and hands-on technical support. A primary initial focus is stewardship of the VAX-31 MSD immunoassay platform, which has advanced to Phase 3, ensuring knowledge transfer and continuity of scientific excellence.
The role involves building, mentoring, and managing a laboratory-based team of scientists responsible for immunoassay development, optimization, troubleshooting, qualification support, method transfer, validation, routine analytical testing, and lifecycle management. The director will strengthen Vaxcyte's immunoassay portfolio by developing fit-for-purpose assays supporting potency, antigenicity, identity, impurity characterization, comparability, release, stability, and lifecycle needs.
Responsibilities include hands-on scientific leadership for assay design, sample preparation strategy, reagent strategy, format selection, signal detection, data analysis, and robustness assessment. The director will lead structured troubleshooting and root-cause analysis for assay variability, reagent performance, matrix effects, and method trending. Additional duties include evaluating and implementing innovative immunoassay technologies (ELISA, MSD, automation-enabled workflows), developing new methods from concept through validation readiness, strengthening analytical control strategies, and overseeing outsourced immunoassay activities with CROs, CDMOs, and contract laboratories.
This position requires deep expertise in CMC execution, GMP readiness, lifecycle management, and the ability to balance hands-on technical work with strategic leadership and team development in a fast-moving clinical-stage biotech environment.
