About The Position
The primary mission of Clinical Immunology and Diagnostics (CID) is to develop and optimize high-quality, high throughput immunoassays that are fit-for-purpose. CID 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 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.
Requirements
- BA/BS in microbiology, immunology, virology, biochemistry, or related discipline with 6+ years of relevant experience.
- Strong verbal and written communication skills.
- Ability to design experiments, analyze and interpret scientific data.
- Strong attention to detail and commitment to operational excellence.
- Ability to work on multiple projects simultaneously.
- Proficient in Microsoft Office 365 applications.
- The ability to effectively design and execute laboratory experiments and communicate results both verbally and in writing.
Nice To Haves
- MBA/MS with 5+ years of experience; OR PhD or JD with 1+ year of experience.
- Strong working knowledge of microbiology, immunology, vaccine research and/or assay development.
- Experience in the execution of clinical testing in support of clinical trials.
- Direct hands-on experience working in a regulated (GCLP/GLP/GMP) environment and familiarity with international regulatory guidelines is preferred.
- Familiarity with clinical trial execution and budget management.
- Professional working proficiency in Mandarin is preferred.
Responsibilities
- 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 requirements.
- Present experimental results at group and project meetings.
- Travel to external laboratories during the year may be required.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
