Senior Scientist, Immunoassay Development, Antibody Critical Reagents & Reference Materials

The role

This role provides scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials. The person will support immunoassays across the vaccine pipeline through laboratory studies and partner with internal teams and external vendors.

What you will do

• Lead and execute laboratory studies for monoclonal antibody generation, screening, characterization, and lifecycle management.
• Develop and execute characterization strategies for antibody reagents.
• Support antibody reagent generation strategies including antigen design and immunization.
• Lead and execute reference standard and assay control activities.
• Develop and execute stability plans for critical reagents and reference materials.
• Support customized immunoassay material generation and qualification.
• Establish qualification and bridging strategies for new reagent and material lots.
• Support inventory lifecycle management.
• Contribute to regulatory-supporting documentation.
• Oversee outsourced activities and manage CRO, CDMO, and vendor interactions.

Required qualifications

• PHD in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with minimum 5 years of relevant biopharmaceutical industry experience; or M.S. in a related discipl
• Hands-on experience with monoclonal antibody generation and characterization.
• Significant experience with antibody reagent generation, screening, characterization, qualification, conjugation, labeling, lot bridging, stability assessment, and lifecycle management.
• Experience managing or supporting immunoassay critical reagents, reference standards, assay controls, calibrators, and customized assay materials used in ligand-binding assays or vaccine analytical me
• Experience planning, executing, and interpreting critical reagent and reference material stability studies.
• Strong understanding of antibody-antigen interactions, assay reagent quality attributes, specificity, affinity, cross-reactivity, epitope behavior, matrix effects, reagent stability, and lot-to-lot co
• Hands-on experience with immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other ligand-binding assay technologies.
• Experience with customized immunoassay materials such as MSD plates, coated plates, labeled detection reagents beads, multiplex panels, assay kits, buffers, and other platform-specific critical compon

Nice to have

• Experience with antibody engineering
• recombinant antibody production
• hybridoma generation
• antibody purification
• antibody conjugation
• biotinylation
• ruthenium labeling
• fluorescent labeling
• bead conjugation
• multiplex panel design

Benefits

• comprehensive benefits
• equity component

About the company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.