Senior Manager, 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 Senior Manager will lead people, manage laboratory execution, and ensure reliable delivery for immunoassays across the vaccine pipeline.

What you will do

• Manage daily immunoassay laboratory operations including study scheduling and staff planning
• Lead, mentor, and manage scientists and research associates
• Assign and prioritize laboratory work based on program needs and staff capability
• Provide technical and operational oversight for assay execution and documentation
• Support development of fit-for-purpose immunoassays for the vaccine pipeline
• Oversee execution of immunoassay development, optimization, and lifecycle studies
• Provide hands-on technical support for troubleshooting and data interpretation
• Support evaluation of innovative immunoassay platforms and technologies
• Coordinate routine analytical testing within the CMC Immunoassay group
• Manage assigned outsourced immunoassay activities with CROs, CDMOs, and vendors

Required qualifications

• PHD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 8 years of relevant biopharmaceutical industry experience; or M.S. in a related d
• Significant hands-on laboratory experience developing, optimizing, troubleshooting, lifecycle-supporting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or othe
• Demonstrated experience leading people, managing laboratory staff, coordinating daily lab operations, assigning work, reviewing data, setting expectations, and supporting staff development
• Experience managing daily laboratory operations, including staff planning, study planning, testing prioritization, sample and reagent readiness, instrument scheduling, data review, documentation, and
• Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other relevant immunoassay tech
• Experience supporting method development, platform evaluation, method transfer, qualification, validation readiness, routine testing, lifecycle management, and analytical control strategy execution
• Experience managing multiple laboratory studies, technical workstreams, testing priorities, outsourced activities, timelines, and deliverables in a fast-paced, matrixed environment
• Strong written and verbal communication skills
• Demonstrated ability to build team capability, foster accountability, manage performance, provide technical coaching, and create a collaborative laboratory culture
• Strong commitment to data integrity, documentation quality, laboratory safety, scientific excellence, accountability, and continuous improvement

Nice to have

• Experience supporting outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, or technology partners
• Experience working in or supporting GMP-regulated analytical environments
• Hands-on experience with MSD platforms
• Hands-on experience with multiplex or other multiplex immunoassay platforms
• Direct experience with vaccines, conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics
• Experience managing or supervising laboratory scientists in analytical development, vaccine CMC, biologics development, QC, ASAT, or related regulated laboratory environments
• Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management of vaccine or biologics programs
• Experience managing routine analytical testing, method transfer, validation-support activities, bridging, comparability, critical reagent qualification, reference material qualification, and long-term
• Experience managing outsourced immunoassay development, validation, platform evaluation, or routine testing activities with external laboratories or technology partners
• Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools

Benefits

• comprehensive benefits
• equity component

About the company

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