Director Immunoassay Development

Summary:

Vaxcyte is seeking an accomplished Director, Immunoassay Development to join the CMC Immunoassay group. This role will provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline.

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.

Essential Functions:

• Help establish, lead, and scale the Immunoassay capability within the CMC Immunoassay group, 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, 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 CMC Immunoassay group, 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, including resource planning, timeline management, deliverable tracking, and risk escalation.
• Establish a high-performing laboratory culture grounded in scientific rigor, accountability, collaboration, transparency, data integrity, hands-on problem solving, operational discipline, and continuous learning.
• Contribute to regulatory submissions, health authority responses, technical reports, method development reports, validation strategies, comparability packages, platform evaluation summaries, and BLA-supporting documentation.
• Represent Immunoassay Development in technical governance forums, program teams, cross-functional reviews, vendor discussions, and external collaborations as needed.

Requirements: 

• PhD in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related field (or equivalent experience) with a minimum of 10 years of experience. Other combinations of education and/or experience may be considered.
• Demonstrated scientific depth, independent immunoassay development leadership, complex troubleshooting experience, and ability to lead cross-functional technical workstreams are required.
• Significant hands-on, lab-based experience developing, optimizing, troubleshooting, transferring, validating, lifecycle-managing, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical environments.
• Demonstrated expertise in immunoassay method development, including assay format selection, reagent strategy, sample preparation, assay optimization, robustness assessment, qualification, validation readiness, method transfer, and lifecycle management.
• Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, 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 platform learnings into fit-for-purpose analytical strategies.
• Experience developing or improving potency, antigenicity, identity, or impurity assays supporting vaccine or biologics release, stability, comparability, process development, method transfer, validation, routine testing, or regulatory submissions.
• Experience overseeing outsourced immunoassay activities, including CRO, CDMO, contract testing laboratory, reagent vendor, or external technology partner interactions.
• Demonstrated ability to manage daily laboratory operations, including study planning, staff planning, sample and reagent readiness, testing prioritization, data review, documentation, and technical support.
• Strong working knowledge of global regulatory expectations for analytical methods supporting vaccines and biologics, including FDA, EMA, ICH, and GMP expectations.
• Solid understanding of protein chemistry, polysaccharide chemistry, conjugation chemistry, antigen structure, antibody-antigen interactions, and biological sample matrix effects as applied to vaccine analytical development.
• Hands-on experience with MSD platforms is highly desirable.
• Experience working in or supporting GMP-regulated analytical environments is desired, including familiarity with method qualification, validation, transfer, change control, deviations, investigations, CAPA, data integrity, and lifecycle management.
• Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.
• Demonstrated experience leading, mentoring, and developing laboratory scientists, including building team capability, setting priorities, managing performance, providing technical coaching, and fostering a collaborative culture.
• Proven ability to manage multiple technical workstreams, outsourced activities, validation-support activities, routine testing needs, resources, timelines, and deliverables in a fast-paced, matrixed environment.
• Strong scientific judgment and the ability to make sound technical recommendations when working with incomplete, complex, or conflicting data.
• Excellent written and verbal communication skills, with the ability to clearly communicate complex technical concepts to cross-functional stakeholders, senior leaders, external partners, and regulatory audiences.
• Strong commitment to data integrity, documentation quality, scientific excellence, accountability, and continuous improvement.

Preferred Qualifications:

• Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial launch, or lifecycle management of vaccine or biologics programs.
• Direct experience supporting analytical methods used for GMP release and stability testing.
• Experience with immunoassay transfer, validation, bridging, comparability, critical reagent qualification, reference material qualification, and long-term method performance monitoring.
• Experience managing outsourced immunoassay development, validation, platform evaluation, or routine testing activities with external laboratories or technology partners.
• Experience developing alternative or next-generation immunoassay methods to strengthen analytical capability and support long-term control strategy.
• Experience interacting with global health authorities on analytical, potency, antigenicity, or immunoassay-related topics.
• Experience building or scaling analytical capabilities or laboratory teams within a growing organization.
• Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools.
• Experience with multivalent or highly complex vaccine programs.