Director, Immunoassay Development

Role: Director of Immunoassay Development leading scientific and strategic efforts within Vaxcyte's CMC team. Responsibilities: establish and scale immunoassay capabilities, including assay development, optimization, troubleshooting, validation, transfer, and lifecycle management; oversee outsourced activities; support GMP readiness and regulatory submissions; and develop immunoassays for vaccine potency, identity, impurity, and characterization across preclinical to late-stage development. Lead and mentor assay scientists, ensuring high-quality execution and continuous improvement. Requirements: PhD in Biochemistry, Immunology, Analytical Chemistry, or related field with 10+ years of experience; extensive hands-on immunoassay development expertise (ELISA, MSD preferred); proven leadership in regulated vaccine or biologics environments; strong troubleshooting and assay design skills; experience with GMP, validation, and outsourcing; solid knowledge of protein chemistry and biological sample matrices. Preferred: experience supporting late-stage vaccine programs, GMP validation, automation, multiplex assays, and interactions with health authorities. Work setup: onsite in San Carlos, CA; reports to Senior Director, Global Analytical Lead. High-value specifics: vaccine development, biologics, conjugated or multivalent vaccines, GMP, regulatory compliance, assay lifecycle management, and optimizing immunoassay platforms for clinical and commercial use.