Director, Immunoassay Development

Vaxcyte•San Carlos, CA

5h•Onsite

About The Position

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. A key initial focus of this role will be stewardship of the VAX-31 MSD immunoassay platform, which has been developed and advanced to Phase 3 through extensive internal leadership spanning clinical serology, GLP studies, and immunoassay development. The successful candidate will work in close partnership with current immunoassay leadership to ensure comprehensive knowledge transfer, continuity of scientific and execution excellence, and the long-term robustness of the immunoassay strategy as accountability and responsibility intentionally transition into Analytical Development. This is a hands-on scientific leadership role anchored in CMC execution, GMP readiness, and lifecycle management of immunoassays supporting vaccine development, lot release and stability testing and commercialization.

Requirements

Ph.D. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related field (or equivalent experience) with a minimum of 10 years of experience. Other combinations of education and/or experience may be considered.
Significant hands-on experience developing immunoassays within vaccine CMC, analytical development, or other regulated laboratory environments.
Expert-level, hands-on experience with MSD (Meso Scale Discovery) or closely related immunoassay platforms, including method development, optimization, troubleshooting, and lifecycle support.
Direct experience with conjugated vaccines, including polysaccharide–protein conjugates.
Solid understanding of protein chemistry and conjugation chemistry, particularly as applied to biological drug and vaccine development.
Demonstrated expertise in potency and antigenicity assays supporting vaccine release, stability, and comparability.
Strong working knowledge of GMP and global regulatory expectations (FDA, EMA, ICH) for analytical methods supporting vaccines.
Demonstrated ability to think critically and exercise sound scientific judgment when navigating complex, ambiguous, or conflicting technical and organizational challenges.
Proven track record of scientific problem-solving, including data-driven decision-making and root-cause analysis.
Strong written and verbal communication skills, with the ability to clearly and efficiently communicate technical concepts across interdisciplinary and cross-functional teams.
Ability to operate effectively in a fast-paced, matrixed environment, manage multiple priorities, and meet aggressive timelines.
Project and resource management experience, including planning and coordination of materials, staffing, timelines, and deliverables, with the ability to appropriately escalate issues and risks.

Nice To Haves

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

Responsibilities

Establish and lead a new Immunoassay Development function within Analytical Development, defining scope, strategy, and operating model aligned with CMC and program needs.
For VAX-31, partner closely with current immunoassay leadership to learn and internalize the full development history, scientific rationale, and performance characteristics of the existing MSD-based immunoassay platform.
Serve as scientific steward for the VAX-31 immunoassay, providing troubleshooting, root-cause analysis, and technical problem-solving support to Quality Control (QC) and Analytical Sciences and Technology (ASAT) teams.
Support ASAT activities for VAX-31, including qualification, lifecycle management, and change control of critical immunoassay reagents.
Develop and execute immunoassay strategies to support potency, antigenicity, identity, and trace-level impurity testing for conjugated vaccines across the pipeline.
Lead the development and optimization of antigenicity- and potency-based immunoassays suitable for late-stage development and commercial use.
Drive continuous improvement of existing immunoassays to enhance robustness, QC-friendliness, throughput, and long-term performance, even when methods are already deemed adequate.
Build, mentor, and manage a team of laboratory scientists, fostering a cohesive, innovative, nimble, and high-performing team culture grounded in scientific rigor and accountability.
Provide critical scientific judgment and problem-solving leadership when addressing complex, ambiguous, or conflicting technical challenges across programs.
Manage immunoassay development activities across multiple projects, prioritizing resources, timelines, and deliverables in a fast-paced, matrixed environment; proactively escalate risks and issues to line management and project team as appropriate.
Partner cross-functionally with Process Development, Manufacturing, Quality, Clinical Serology, and Regulatory teams to ensure alignment with overall CMC strategy and program timelines.
Ensure immunoassay methods meet FDA, EMA, and ICH expectations for vaccines and biologics.
Support regulatory submissions and health authority interactions through technical input, data review, and authorship of CMC documentation.
Champion data integrity, scientific excellence, and continuous learning within the immunoassay organization.