Director, Immunoassay Development

Responsibilities

• Establish and lead a new Immunoassay Development function within Analytical Development, defining scope, strategy, and operating models.
• Serve as the scientific steward for the VAX-31 MSD immunoassay platform, providing troubleshooting and technical problem-solving.
• Develop and optimize antigenicity- and potency-based immunoassays to support conjugated vaccine pipelines from preclinical through BLA-stage.
• Build, mentor, and manage a high-performing team of laboratory scientists.
• Partner cross-functionally with Process Development, Manufacturing, Quality, and Regulatory teams to ensure alignment with CMC strategy.
• Ensure all immunoassay methods meet FDA, EMA, and ICH regulatory expectations.
• Support regulatory submissions through technical input and authorship of CMC documentation.

Requirements

• Ph.D. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related field with at least 10 years of experience.
• Significant hands-on experience developing immunoassays within vaccine CMC or regulated analytical development environments.
• Expert-level experience with MSD (Meso Scale Discovery) or closely related immunoassay platforms.
• Direct experience with conjugated vaccines, specifically polysaccharide–protein conjugates.
• Strong working knowledge of GMP and global regulatory expectations (FDA, EMA, ICH).
• Proven track record of scientific problem-solving and data-driven decision-making.

Preferred Qualifications

• Experience supporting late-stage development or commercial vaccine programs.
• Direct interaction with global health authorities regarding analytical or potency topics.
• Experience building or scaling analytical capabilities within a growing organization.
• Background in multivalent or highly complex vaccine programs.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are driven by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.