Why Patients Need You

At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.

What You Will Achieve

The primary mission of Clinical Immunology and High-throughput Operations (CIHO) is to develop and optimize high-quality, high-throughput immunoassays that are fit-for-purpose. CIHO then oversees the compliant execution of these assays to deliver high-quality clinical assay results to support Pfizer’s vaccine clinical research programs. As a member of the Vendor, Reagent, & Sample Logistics (VRSL) team, you will lead the management of clinical assay projects with external laboratories including academic institutions, government laboratories, and contract laboratories, both domestic and international. Your responsibilities will include the oversight of technology transfer of Pfizer-developed assays, clinical sample testing, monitoring of assay performance, assay investigations when needed, and providing general vendor oversight.

In addition, you will demonstrate comprehensive industry knowledge in order to work cross-functionally to identify and qualify new opportunities for collaboration and outsourcing of Pfizer clinical sample testing needs. You will be expected to maintain master testing plans, secure appropriate resource requirements, and provide financial guidance and oversight of the external laboratory budget for multiple programs of moderate complexity. You will leverage technical expertise across your own and related disciplines to interpret and communicate laboratory results and project status both verbally and in writing. You will utilize a positive work ethic, strong interpersonal skills, and be highly collaborative with groups both inside and outside of Pfizer as you may need to lead by influence rather than direct authority.

This position operates with limited supervision. Work and tasks are to be done in a compliant manner according to relevant SOP and GCLP/GLP/GMP guidelines, when required.

How You Will Achieve It

• Serve as a point of contact for various functional groups to manage Pfizer’s clinical sample testing and Pfizer-associated assays at external laboratories supporting VRD programs. Responsibilities include transfer of biofunctional, ligand-binding, serological, and diagnostic assays to external laboratories as well as oversight of staff training, assay documentation, and scientific and organizational leadership to the external laboratory leadership.
• Maintain a 12-month master testing schedule and provide financial guidance for outsourced activities.
• Routinely monitor assay performance at external laboratories.
• Actively contribute to assay investigations and problem solving that arise in routine and non-routine assay testing.
• Actively contribute to regulatory queries related to work performed at external laboratories.
• Evaluate, critique, recommend, and qualify external laboratories and/or their in-house assays for outsourcing of Pfizer clinical sample testing. Ensure that assays performed at external laboratories supporting Pfizer clinical studies are qualified or validated (as appropriate) and assay-associated tasks performed at external laboratories are done in a compliant fashion, in accordance with prevailing SOPs, and GCLP/GLP/GMP regulations, as appropriate.
• Leverage technical expertise across own and related disciplines to interpret and present experimental results; provide scientific, technical and management direction to external laboratory leaders and managers.
• Actively monitor industry trends, models, and processes for outsourcing and recommend improvements, enhancements, savings, and/or synergies to senior leadership for approval.
• Manage and oversee the generation of contracts and agreements with external laboratories, including, but not limited to, master service agreements, quality agreements, and scope of work documents.
• Help execute audits and manage productive collaborative relationships with external laboratories.
• Independently perform all aspects of work to support clinical and development studies with minimal support from direct supervisor.
• Effectively communicate experimental designs, strategy, and results verbally and in writing. Authors, reviews, and approves standard operating procedures (SOPs) and technical reports.
• Satisfactorily complete all GCLP/GLP/GMP and safety training in conformance with VRD & HCID requirements.
• Where applicable, perform job responsibilities in compliance with GCLP/GLP/GMP and all other regulatory agency re