About this role
Job title: Associate Director, Immunoassay Development
About the Role Vaxcyte seeks an accomplished Associate Director, Immunoassay Development to join the Global Analytical Development organization. This role provides scientific and strategic leadership for immunoassay development across the vaccine pipeline, including platform evaluation and innovation, outsourcing and vendor oversight, method transfer, validation, lifecycle management, routine analytical testing, and an immunoassay control strategy. It is an onsite, laboratory-based leadership role with significant hands-on responsibilities and daily engagement in laboratory operations, experimental planning, assay execution, study oversight, data review, and technical support.
What You'll Do
- Lead and directly contribute to assay design, assay execution, data analysis, troubleshooting, method optimization, platform evaluation, transfer readiness, validation readiness, and routine non-GMP or GMP-supporting analytical testing for complex conjugated vaccines and other pipeline assets.
- Provide hands-on leadership for immunoassay development across potency, antigenicity, identity, and impurity-related assays in CMC or regulated environments; strengthen hands-on capability and drive assay robustness and long-term control strategy.
- Drive platform evaluation and innovation, assess alternative immunoassay formats (ELISA, MSD, Luminex, and related ligand-binding assays), and support modernization and multiplexing efforts.
- Oversee outsourced immunoassay activities with CROs/CDMOs and reagent vendors, including scope definition, study design reviews, data reviews, and vendor communication.
- Collaborate with internal and external immunoassay SMEs and functions (Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Regulatory, Program Management, CROs, CDMOs, contract testing laboratories, and technology partners) to support method development, outsourcing, validation readiness, routine testing, GMP readiness, and long-term assay lifecycle strategy.
What We're Looking For
- Strong technical expertise in immunoassay development for vaccines or biologics; demonstrated experience developing, optimizing, troubleshooting, and lifecycle-supporting potency-, antigenicity-, identity-, and impurity-related immunoassays in CMC or regulated environments.
- Hands-on laboratory leadership with the ability to plan, execute, interpret, and troubleshoot assays; experience with ELISA, MSD, Luminex, and other ligand-binding formats.
- Experience with platform evaluation, innovation, and long-term analytical control strategy across vaccine pipelines.
- Experience coordinating with CROs/CDMOs, contract testing laboratories, and external technology partners; strong data review and problem-solving skills.
Nice to Have
- Experience with conjugated vaccines.
- Experience with fit-for-purpose immunoassays from concept through validation and lifecycle strategy.
- Experience with multiplexing, throughput, sensitivity, specificity, robustness improvements.
- GMP readiness, comparability testing, and regulatory support experience.
Compensation & Benefits
- Not disclosed.