Director, Immunoassay Development

Director, Immunoassay Development

Vaxcyte is seeking an accomplished Director, Immunoassay Development to establish and lead a dedicated analytical function focused on immunoassay development for complex conjugated vaccines. This role will build and manage a laboratory-based team responsible for developing, sustaining, and continuously improving potency- and antigenicity-based immunoassays to support CMC development from preclinical through BLA-stage programs and commercialization.

A key initial focus of this role will be stewardship of the VAX-31 MSD immunoassay platform, which has been developed and advanced to Phase 3 through extensive internal leadership spanning clinical serology, GLP studies, and immunoassay development. The successful candidate will work in close partnership with current immunoassay leadership to ensure comprehensive knowledge transfer, continuity of scientific and execution excellence, and the long-term robustness of the immunoassay strategy as accountability and responsibility intentionally transition into Analytical Development.

This is a hands-on scientific leadership role anchored in CMC execution, GMP readiness, and lifecycle management of immunoassays supporting vaccine development, lot release and stability testing and commercialization.

• Help establish, lead, and scale the Immunoassay capability within Global Analytical Development, including defining scope, operating model, technical standards, platform strategy, outsourcing approach, validation support model, routine testing model, and control strategy priorities aligned with CMC and program needs.
• Provide daily laboratory leadership, including experimental planning, laboratory schedule coordination, study prioritization, reagent and sample readiness, data review, documentation expectations, instrument and workflow oversight, and hands-on technical support to ensure high-quality execution.
• Build, mentor, and manage a laboratory-based team of scientists responsible for immunoassay development, optimization, troubleshooting, qualification support, method transfer, validation support, routine analytical testing, lifecycle management, and continuous improvement.
• Strengthen Vaxcyte's immunoassay portfolio by developing fit-for-purpose immunoassays that support potency, antigenicity, identity, impurity, characterization, comparability, release, stability, and lifecycle needs across the vaccine pipeline.
• Provide hands-on scientific leadership for assay design, sample preparation strategy, reagent strategy, plate or bead format selection, signal detection approach, data analysis model, system suitability expectations, and robustness assessment.
• Lead structured immunoassay troubleshooting and root-cause analysis for assay variability, reagent performance, sample preparation, matrix effects, antigen accessibility, signal response, curve behavior, recovery, precision, specificity, robustness, and long-term method trending.
• Evaluate and implement innovative or alternative immunoassay technologies, including ELISA, MSD, Luminex, automation-enabled workflows, and other relevant ligand-binding assay formats.
• Develop new immunoassay methods from concept through optimization, qualification readiness, transfer readiness, validation readiness, and lifecycle strategy, including control strategy considerations and documentation suitable for CMC decision-making.
• Strengthen immunoassay analytical control strategies, including critical reagent strategy, reference material strategy, assay controls, system suitability, sample preparation, acceptance criteria, bridging approaches, trending, stability planning, and lifecycle monitoring.
• Oversee 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 performance oversight, and deliverable acceptance.
• Support immunoassay method validation activities in partnership with ASAT, QC, Quality, Regulatory, and external testing partners, including validation strategy, protocol input, acceptance criteria, data interpretation, deviation support, and final report review.
• Support routine immunoassay testing needs 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 QC and ASAT teams in technical questions related to release, stability, comparability, PPQ, method transfer, validation readiness, and commercial readiness activities.
• Develop phase-appropriate immunoassay strategies across the vaccine pipeline, ensuring methods and control strategies are aligned with preclinical, clinical, late-stage, BLA, commercial, and lifecycle needs.
• Manage immunoassay development, outsourcing, validation-support, routine testing, and platform innovation activities across multiple projects,…