Vaxcyte
Director, Immunoassay Development
San Carlos, California, United States · Director
Sponsorship not specified$213k-$250kDetected 18 hours ago
Data AnalysisAccessibilityCustomer SupportGMPFDA RegulatoryExperimental DesignProtein AnalysisAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingMentoring
About the role
- Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
- Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
- Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
Responsibilities
- Vaxcyte is seeking an accomplished Director, Immunoassay Development to establish and lead a dedicated analytical function focused on immunoassay development for complex conjugated vaccines.
- This role will build and manage a laboratory-based team responsible for developing, sustaining, and continuously improving potency- and antigenicity-based immunoassays to support CMC development from preclinical through BLA-stage programs and commercialization.
- Evaluate and implement innovative or alternative immunoassay technologies, including ELISA, MSD, Luminex, automation-enabled workflows, and other relevant ligand-binding assay formats.
Requirements
- 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, complex troubleshooting experience, and ability to lead cross-functional technical workstreams are required.
- Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, ELISA, Luminex, or other relevant immunoassay technologies.
- Proven ability to troubleshoot complex immunoassay performance trends using structured, data-driven root-cause analysis approaches.
- Experience evaluating alternative or innovative immunoassay platforms and translating platform learnings into fit-for-purpose analytical strategies.
- Hands-on experience with MSD platforms is highly desirable.
- Strong working knowledge of global regulatory expectations for analytical methods supporting vaccines and biologics, including FDA, EMA, ICH, and GMP expectations.
- Strong scientific judgment and the ability to make sound technical recommendations when working with incomplete, complex, or conflicting data.
Nice to have
- Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial launch, or lifecycle management of vaccine or biologics programs.
- Direct experience supporting analytical methods used for GMP release and stability testing.
- Experience with immunoassay transfer, validation, bridging, comparability, critical reagent qualification, reference material qualification, and long-ter
- Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.
- Hands-on experience with Luminex or other multiplex immunoassay platforms is a plus.
Compensation
- $213k-$250k
Company info
- Join our Mission to Protect Humankind!
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This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.