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Associate Director, Immunoassay Development
San Carlos, California, United States
Join our Mission to Protect Humankind!
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.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is seeking an accomplished Associate Director, Immunoassay Development to join the Global Analytical Development organization. This role will provide scientific and strategic leadership for immunoassay development across Vaxcyte's vaccine pipeline, supporting platform evaluation and innovation, outsourcing and vendor oversight, method transfer, validation, lifecycle management, routine analytical testing, and immunoassay control strategy.
This is an onsite, laboratory-based scientific leadership role with significant hands-on responsibilities and daily engagement in laboratory operations, experimental planning, assay execution, study oversight, data review, and technical support.
The Associate Director will lead and directly contribute to assay design, assay execution, data analysis, troubleshooting, method optimization, platform evaluation, method transfer support, validation readiness, and routine non-GMP or GMP-supporting analytical testing for complex conjugated vaccine programs and other vaccine pipeline assets.
The successful candidate will bring strong technical expertise in immunoassay development for vaccines or biologics, with demonstrated experience developing, optimizing, troubleshooting, and lifecycle-supporting potency-, antigenicity-, identity-, and impurity-related immunoassays in CMC or regulated analytical environments.
A key responsibility of this role will be to strengthen Vaxcyte's hands-on immunoassay capability by developing new fit-for-purpose immunoassays, supporting platform evaluation and innovation, advancing assay robustness, and contributing to analytical control strategy across the vaccine pipeline.
The Associate Director will work closely with internal and external immunoassay subject matter experts, Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology, 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.
Essential Functions:
- Contribute to the establishment and growth of the Immunoassay Development Capability within the Global Analytical Development organization, with emphasis on hands-on immunoassay development, troubleshooting, method optimization, platform evaluation, routine testing, outsourcing support, validation readiness, and control strategy execution.
- Engage daily in laboratory operations, including experimental planning, assay execution, sample and reagent readiness, study scheduling, instrument and workflow coordination, data review, documentation, and hands-on technical support.
- Lead and directly execute laboratory studies for immunoassay development, optimization, troubleshooting, qualification support, method transfer, validation support, lifecycle management, and routine analytical testing.
- Provide hands-on technical leadership for immunoassays supporting potency, antigenicity, identity, impurity, characterization, comparability, release, and stability needs for complex conjugated vaccines and other vaccine pipeline programs.
- Design, execute, and interpret experiments to evaluate assay format, sample preparation, reagent strategy, plate or bead configuration, signal detection, curve behavior, recovery, precision, specificity, robustness, and system suitability.
- Independently troubleshoot immunoassay performance trends using structured, data-driven root-cause analysis approaches and clear experimental plans.
- Support development of new fit-for-purpose immunoassay methods from concept through optimization, qualification readiness, transfer readiness, validation readiness, and lifecycle strategy.
- Assess alternative and innovative immunoassay approaches, platforms, and formats to support assay modernization, multiplexing, throughput, sensitivity, specificity, robustness, and long-term control strategy.
- Support comparative evaluation of immunoassay technologies, including ELISA, MSD, Luminex, and other relevant ligand-binding assay formats.
- Perform and oversee routine analytical testing within the CoE, including development-stage testing, characterization testing, platform evaluation studies, method bridging, comparability support, reagent qualification, and other non-GMP or GMP-supporting analytical activities.
- Support outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, and external technology partners, including technical scope definition, study design review, data review, vendor communication, and deliverable tracking.
- Support immunoassay method validation activities in partnership with ASAT, QC, Quality, Regulatory, and external testing partners, including protocol input, acceptance criteria, data interpretation, deviation support, and final report review.
- Partner with internal and external subject matter experts to understand assay design, critical reagents, reference materials, method performance attributes, and control strategy needs.
- Support QC and ASAT teams in technical questions related to release, stability, comparability, PPQ, method transfer, validation readiness, and commercial readiness activities.
- Contribute to immunoassay analytical control strategies, including critical reagent strategy, reference material strategy, sample preparation, assay controls, system suitability, bridging plans, trending, and lifecycle monitoring.
- Manage assigned immunoassay development, troubleshooting, outsourcing, validation-support, platform evaluation, and routine testing activities, including study planning, resource coordination, timeline management, data review, deliverable tracking, and risk escalation.
- Mentor and provide technical guidance to laboratory scientists on experimental design, assay execution, data interpretation, troubleshooting, documentation, and good laboratory practices.
- Contribute to regulatory submissions, health authority responses, technical reports, method development reports, validation strategies, comparability packages, platform evaluation summaries, and BLA-supporting documentation.
- Represent Immunoassay Development in technical project meetings, cross-functional reviews, vendor discussions, and external collaborations as needed.
Requirements:
- PhD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 7 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 10 years of relevant biopharmaceutical industry experience. Other combinations of education and/or experience may be considered.
- Significant hands-on laboratory experience developing, optimizing, troubleshooting, transferring, validating, lifecycle-supporting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical environments.
- Demonstrated expertise in immunoassay method development, including assay format selection, antibody reagent strategy, reagent screening, reagent evaluation and selection, sample preparation, assay optimization, robustness assessment, qualification, validation readiness, and lifecycle management.
- Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, 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 experimental data into method development recommendations.
- Experience developing or improving potency, antigenicity, identity, or impurity assays supporting vaccine or biologics release, stability, comparability, process development, method transfer, validation, routine testing, or regulatory submissions.
- Experience supporting outsourced immunoassay activities, including CRO, CDMO, contract testing laboratory, reagent vendor, or external technology partner interactions.
- Demonstrated ability to support daily laboratory operations, including study planning, sample and reagent readiness, testing prioritization, data review, documentation, and technical troubleshooting.
- Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.
- Solid understanding of protein chemistry, polysaccharide chemistry, conjugation chemistry, antigen structure, antibody-antigen interactions, and biological sample matrix effects as applied to vaccine analytical development.
- Hands-on experience with MSD platforms is highly desirable.
- Hands-on experience with Luminex or other multiplex immunoassay platforms is a plus.
- Experience working in or supporting GMP-regulated analytical environments is desired, including familiarity with method qualification, validation, transfer, change control, deviations, investigations, CAPA, data integrity, and lifecycle management.
- Working knowledge of global regulatory expectations for analytical methods supporting vaccines and biologics, including FDA, EMA, ICH, and GMP expectations.
- Demonstrated ability to mentor, train, and provide technical guidance to laboratory scientists.
- Strong ability to manage multiple laboratory studies, technical workstreams, outsourced activities, validation-support activities, routine testing needs, timelines, and deliverables in a fast-paced, matrixed environment.
- Strong scientific judgment and the ability to make sound technical recommendations when working with incomplete, complex, or conflicting data.
- Excellent written and verbal communication skills, with the ability to clearly communicate technical concepts, study results, risks, and recommendations to cross-functional stakeholders and external partners.
- Strong commitment to data integrity, documentation quality, scientific excellence, accountability, and continuous improvement.
Preferred Qualifications:
- 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-term method performance monitoring.
- Experience managing or supporting outsourced immunoassay development, validation, platform evaluation, or routine testing activities with external laboratories or technology partners.
- Experience developing alternative or next-generation immunoassay methods to strengthen analytical capability and support long-term control strategy.
- Experience contributing to health authority responses or regulatory submissions on analytical, potency, antigenicity, or immunoassay-related topics.
- Experience helping build or scale analytical capabilities, Centers of Excellence, or laboratory teams within a growing organization.
- Experience with multivalent or highly complex vaccine programs.
- Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools.
Reports to: Senior Director, Global Analytical Lead – Commercial Readiness and Analytical Strategy
Location: San Carlos, CA
Work Arrangement: Onsite
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $190,000 - $220,000
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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