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. The role will build and manage a laboratory-based team responsible for potency- and antigenicity-based immunoassays across CMC development from preclinical to commercialization, with an initial focus on stewarding the VAX-31 MSD immunoassay platform (Phase 3). This hands-on scientific leadership role anchors in CMC execution, GMP readiness, and lifecycle management of immunoassays supporting vaccine development, lot release, stability testing, and commercialization.

What You'll Do

• 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 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.

What We're Looking For

• Proven experience leading immunoassay development programs in vaccines or complex biologics, with a track record of taking assays from concept through qualification/validation.
• Hands-on scientific leader able to mentor scientists, build teams, and manage a lab-based immunoassay function.
• Deep expertise in immunoassay platforms (ELISA, MSD, Luminex) and other ligand-binding formats; experience with sample preparation, reagent strategy, plate/bead formats, and signal detection.
• Strong background in CMC, GMP readiness, GLP/QA, and regulatory readiness (BLA/CMC) and collaboration with ASAT, QC, and Regulatory.
• Experience with outsourcing management of CROs/CDMOs and vendor oversight, data review, and cross-functional partnership.
• Excellent data analysis, troubleshooting, root-cause analysis, and problem-solving skills.
• Strong communication and leadership capabilities to drive strategy and execution across functions.
• Familiarity with the VAX-31 platform is a plus.