Director, Immunoassay Development

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 lead a laboratory-based team of scientists to support immunoassays across the vaccine pipeline.

What you will do

• Establish, lead, and scale the Immunoassay capability within the CMC Immunoassay group
• Provide daily laboratory leadership including experimental planning and study prioritization
• Build, mentor, and manage a laboratory-based team of scientists
• Develop fit-for-purpose immunoassays to support the vaccine pipeline
• Provide hands-on scientific leadership for assay design and reagent strategy
• Lead structured immunoassay troubleshooting and root-cause analysis
• Evaluate and implement innovative or alternative immunoassay technologies
• Develop new immunoassay methods from concept through lifecycle strategy
• Oversee outsourced immunoassay activities with CROs, CDMOs, and vendors
• Support immunoassay method validation activities and routine testing needs

Required qualifications

• PhD in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related field (or equivalent experience) with a minimum of 10 years of experience
• Demonstrated scientific depth, independent immunoassay development leadership, and complex troubleshooting experience
• Significant hands-on, lab-based experience in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical environments
• Demonstrated expertise in immunoassay method development, optimization, and lifecycle management
• Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, or other relevant technologies
• Proven ability to troubleshoot complex immunoassay performance trends using data-driven root-cause analysis
• Experience evaluating alternative or innovative immunoassay platforms
• Experience developing or improving potency, antigenicity, identity, or impurity assays
• Experience overseeing outsourced immunoassay activities
• Demonstrated ability to manage daily laboratory operations
• Strong working knowledge of global regulatory expectations including FDA, EMA, ICH, and GMP
• Solid understanding of protein chemistry, polysaccharide chemistry, conjugation chemistry, antigen structure, antibody-antigen interactions, and biological sample matrix effects

Nice to have

• Hands-on experience with MSD platforms
• Experience working in or supporting GMP-regulated analytical environments
• Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics
• Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial launch, or lifecycle management
• Direct experience supporting analytical methods used for GMP release and stability testing
• Experience with immunoassay transfer, validation, bridging, comparability, and reference material qualification
• Experience managing outsourced immunoassay development, validation, or routine testing activities
• Experience developing alternative or next-generation immunoassay methods
• Experience interacting with global health authorities
• Experience building or scaling analytical capabilities or laboratory teams

Benefits

• Comprehensive benefits
• Equity component

About the company

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