What You Will Achieve

• Clinical Immunology & Diagnostics (CID) develops and optimizes high-quality, high-throughput immunoassays that are fit-for-purpose and oversees compliant assay execution to support Pfizer’s vaccine clinical research programs. In this role, you will serve as a key member of the Vendor, Reagent, & Sample Logistics (VRSL) team, coordinating clinical assay projects with external laboratories, including academic institutions, government laboratories, and contract laboratories in both domestic and international settings.

• You will support technology transfer for Pfizer-developed assays, clinical sample testing, assay performance monitoring, issue investigation, and vendor oversight. You will also work cross-functionally to help identify and qualify new collaboration and outsourcing opportunities, maintain testing plans and timelines, support budget tracking, and contribute to the effective execution of multiple programs of moderate complexity.

• Success in this position requires strong project coordination skills, sound technical judgment, and the ability to communicate laboratory results, project status, risks, and next steps clearly across functions. You will apply scientific expertise, operational discipline, and collaborative problem-solving to support work within Pfizer and with external partners.

• This position operates under managerial supervision, with independence to manage day-to-day responsibilities and complete assigned tasks in accordance with relevant SOPs and applicable GCLP/GLP/GMP guidelines, as required.

How You Will Achieve It

• Serve as a point of contact for cross-functional teams supporting Pfizer clinical sample testing and Pfizer-associated assays at external laboratories for VRD programs.

• Maintain testing schedules, track milestones, and provide budget-related support for outsourced activities.

• Monitor assay performance at external laboratories and escalate risks, issues, and trends, as appropriate.

• Support assay investigations and issue resolution during routine and non-routine testing.

• Support the development of responses to regulatory queries related to work performed at external laboratories.

• Evaluate and help qualify external laboratories and/or in-house assays for outsourced Pfizer clinical sample testing.

• Interpret and present experimental results and provide scientific support to external laboratory teams and internal stakeholders.

• Monitor outsourcing trends and recommend process improvements, efficiencies, and synergies.

• Support contracts and agreements with external laboratories, including master service agreements, quality agreements, and scope of work documents.

• Support audits and maintain productive collaborative relationships with external laboratories.

• Execute responsibilities independently while escalating issues and seeking guidance, as needed, under managerial supervision.

• Communicate experimental strategies and results effectively; contribute to SOPs and technical reports.

• Satisfactorily complete all GCLP/GLP/GMP and safety training in conformance with VRD & HCID requirements.

• Perform job responsibilities in compliance with GCLP/GLP/GMP and all other regulatory agency requirements.

• Present experimental results, project updates, and key issues at group and project meetings.

• Travel to external laboratories, as needed, may be required throughout the year.

Qualifications

Must-Have

Master’s, or Bachelor’s degree in microbiology, immunology, virology, biochemistry, or related discipline with minimum:

• BA/BS: 4+ years

• MBA/MS: 2+ years

• Strong verbal and written communication skills, with the ability to collaborate effectively across cross-functional teams and external partners.

• Ability to design experiments and analyze and interpret scientific data.

• Strong attention to detail, organizational skills, and commitment to operational excellence.

• Ability to manage multiple priorities, timelines, and projects simultaneously.

• Proficiency in Microsoft Office 365 applications, standard project-tracking, and AI tools.

• Demonstrated ability to design and execute laboratory experiments and communicate results effectively, both verbally and in writing.

Nice-to-Have

• Strong working knowledge of microbiology, immunology, vaccine research, and/or assay development.

• Experience supporting clinical testing for clinical trials.

• Hands-on experience working in a regulated (GCLP/GLP/GMP) environment and familiarity with international regulatory guidelines.

• Familiarity with clinical trial execution, vendor oversight, and budget tracking.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform work while standing/sitting.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position may require evening work to meet critical business timelines.

Relocation support available

Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.