Scientist, Immunoassay Development

Summary:

Vaxcyte is seeking an accomplished 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.

This is an onsite, laboratory-based role requiring daily engagement in assay execution, experimental planning, sample and reagent preparation, instrument operation, data analysis, documentation, troubleshooting support, and technical communication. Ph.D. candidates are preferred, while M.S. and B.S. candidates with strong relevant industry experience will also be considered.

Essential Functions:

• Perform hands-on laboratory work to support immunoassay development, optimization, platform evaluation, method transfer support, validation readiness, lifecycle management, and routine analytical testing.
• Engage daily in laboratory operations, including assay execution, reagent preparation, sample handling, study setup, instrument use, data review, documentation, laboratory organization, and coordination of testing priorities.
• Design and execute experiments under scientific guidance to support fit-for-purpose immunoassay development for potency, antigenicity, identity, impurity, characterization, comparability, release, and stability needs.
• Support evaluation of immunoassay platforms and formats, including ELISA, MSD, bead-based assays, multiplex assays, automation-enabled workflows, and other ligand-binding technologies.
• Support immunoassay troubleshooting studies by executing structured experiments, analyzing data, documenting observations, and communicating technical findings.
• Generate, analyze, and interpret immunoassay data, including standard curves, sample interpolation, dilution response, recovery, precision, assay controls, system suitability, and robustness-related outputs.
• Support routine analytical testing within the CMC Immunoassay, including development-stage testing, characterization testing, platform evaluation studies, comparability support, reagent qualification, reference material qualification, and GMP-supporting testing.
• Support critical reagent and reference material activities, including reagent preparation, lot comparison, qualification-support testing, stability study support, inventory tracking, and documentation.
• Maintain accurate and timely laboratory records, including ELN entries, study records, assay worksheets, reagent records, data summaries, technical memos, and method development documentation.
• Support outsourced immunoassay activities as needed, including sample preparation, shipment coordination, data review support, study tracking, and internal communication.
• Collaborate with scientists, senior scientists, Associate Directors, and the Director to plan experiments, review data, troubleshoot assays, and prioritize laboratory work.

Requirements:

• PHD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline is preferred with 0 to 2 years of relevant biopharmaceutical industry or post-graduate laboratory experience; or M.S. in a related discipline with a minimum of 5 years of relevant biopharmaceutical industry laboratory experience; or B.S. in a related discipline with a minimum of 8 years of relevant biopharmaceutical industry laboratory experience.
• Hands-on laboratory experience executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, bioanalytical development, or other analytical laboratory environments.
• Experience with immunoassay method development or assay execution, including reagent preparation, sample preparation, assay optimization, data analysis, assay controls, and documentation.
• Technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other relevant immunoassay technologies.
• Experience analyzing immunoassay data, including standard curves, sample response, dilution response, recovery, precision, assay controls, and system suitability criteria.
• Experience working in or supporting GMP, GLP, or 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.