Staff Scientist, Immunoassay Development

Vaxcyte•San Carlos, CA

2d•$209,000 - $244,000•Onsite

About The Position

Vaxcyte is seeking an accomplished Staff Scientist, 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. The Staff Scientist will serve as a hands-on technical expert responsible for strengthening Vaxcyte’s immunoassay capability across the vaccine pipeline. This includes developing new fit-for-purpose immunoassays, evaluating innovative immunoassay platforms, advancing assay robustness, supporting method transfer and validation readiness, contributing to immunoassay control strategy, and providing senior-level scientific guidance to cross-functional teams. This is not a primary people-management role. The Staff Scientist may mentor junior scientists and influence technical direction across programs, but the primary accountability is scientific depth, independent technical contribution, experimental strategy, complex data interpretation, and advancement of immunoassay capability.

Requirements

PhD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline is preferred with a minimum of 8 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 13 years of relevant biopharmaceutical industry experience; or B.S. in a related discipline with a minimum of 16 years of relevant biopharmaceutical industry experience.
Significant hands-on, lab-based experience developing, optimizing, troubleshooting, transferring, lifecycle-supporting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical environments.
Demonstrated scientific depth in immunoassay method development, including assay format selection, reagent strategy, sample preparation, assay optimization, robustness assessment, qualification support, validation readiness, method transfer support, and lifecycle management.
Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other relevant immunoassay technologies.
Demonstrated ability to independently design experiments, interpret complex data, troubleshoot assay performance trends, and make sound scientific recommendations.
Experience evaluating innovative immunoassay platforms and translating platform learnings into fit-for-purpose analytical strategies.
Experience supporting potency, antigenicity, identity, impurity, characterization, comparability, release, stability, process development, method transfer, validation-support, routine testing, or regulatory-supporting assays.
Experience contributing to immunoassay control strategies, including critical reagents, reference materials, assay controls, system suitability, bridging, trending, and lifecycle monitoring.
Experience supporting outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, or technology partners is desired.
Experience working in or supporting GMP-regulated analytical environments is desired.
Hands-on experience with MSD platforms is highly desirable.
Hands-on experience with multiplex or other multiplex immunoassay platforms is a plus.
Demonstrated ability to mentor junior scientists and influence technical direction without relying on formal people-management authority.
Strong written and verbal communication skills, with the ability to clearly communicate complex scientific concepts, data interpretation, technical risks, and recommendations.
Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.

Nice To Haves

Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management of vaccine or biologics programs.
Experience contributing to regulatory submissions, health authority responses, technical reports, method development reports, or validation-support documentation.
Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools.
Experience helping build or scale analytical capabilities or technical platforms within a growing organization.

Responsibilities

Serve as a senior technical expert and individual contributor for immunoassay development across Vaxcyte’s vaccine pipeline.
Lead and directly execute complex laboratory studies supporting immunoassay development, optimization, platform evaluation, qualification readiness, validation readiness, method transfer support, lifecycle management, and routine analytical testing.
Develop new fit-for-purpose immunoassays supporting potency, antigenicity, identity, impurity, characterization, comparability, release, stability, and lifecycle needs.
Provide scientific leadership for assay design, including assay format selection, sample preparation strategy, reagent strategy, plate or bead format selection, signal detection approach, system suitability, data analysis model, robustness assessment, and control strategy considerations.
Evaluate innovative and alternative immunoassay platforms and formats, including ELISA, MSD, multiplex assays, bead-based assays, automation-enabled workflows, and other ligand-binding technologies.
Design and execute studies to compare assay platforms and translate experimental findings into scientific recommendations for method selection, optimization, and long-term control strategy.
Independently troubleshoot immunoassay performance trends using structured, data-driven experimental approaches and clear documentation of observations, conclusions, and recommendations.
Interpret complex immunoassay data, including standard curves, sample interpolation, dilution response, parallelism, recovery, precision, specificity, assay controls, system suitability, robustness, comparability, and long-term method performance.
Contribute to immunoassay analytical control strategies, including critical reagent strategy, reference material strategy, sample preparation, assay controls, system suitability, bridging approaches, trending, robustness evaluation, and lifecycle monitoring.
Support routine testing within the CMC Immunoassay, including development-stage testing, characterization testing, platform evaluation studies, comparability support, reagent qualification, reference material qualification, and non-GMP or GMP-supporting analytical activities.
Provide senior-level technical guidance to scientists and research associates on experimental design, assay execution, data interpretation, troubleshooting, documentation, and good laboratory practices.
Support outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, and technology partners by providing technical input, protocol review, data review, issue resolution, and deliverable assessment.
Author and review study protocols, technical reports, method development reports, platform evaluation summaries, validation-support documents, comparability packages, and regulatory-supporting documentation.
Represent Immunoassay Development as a technical subject matter expert in project teams, cross-functional technical discussions, vendor meetings, and internal scientific reviews.
Partner with Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology, Regulatory, Program Management, and external partners to support CMC deliverables and program timelines.
Stay current with emerging immunoassay technologies, platform innovations, automation opportunities, and best practices that may strengthen Vaxcyte’s immunoassay capability.
Perform all work with strong commitment to scientific rigor, data integrity, documentation quality, laboratory safety, accountability, and continuous improvement.