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Pfizer, Inc. Senior Manager, External Assay Management in Minneapolis, Minnesota

This position is within the External Laboratory and Reagent Management (ELRM) group within High-throughput Clinical Immunoassays and Diagnostics (HCID) within Vaccine Research, Development (VRD). The primary function of HCID is to validate robust, high-quality, high-throughput immunoassays and diagnostic assays and their compliant execution to deliver high-quality clinical assay results for Pfizer's vaccine clinical research programs. This position will have the responsibility to manage clinical assay projects with external partners including academic institutions, government laboratories, and contract research organizations (CROs). The role will oversee technology transfer of assays, clinical sample testing, monitoring of assay performance, assay investigations when needed, and provide general vendor oversight. In addition, the incumbent should 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. The incumbent 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. The incumbent must be able to leverage technical expertise across own and related disciplines to interpret and communicate laboratory results and project status both verbally and in writing. The incumbent must have a positive work ethic, strong interpersonal skills, and be highly collaborative with groups both inside and outside of Pfizer as they may need to lead by influence rather than direct authority. This position operates with limited supervision. Work and tasks managed are to be done in a compliant manner according to relevant SOP guidelines and GCLP/GLP/GMP guidelines, when required. How You Will Achieve It Serve as point of contact for various functional groups to manage Pfizer's clinical sample testing and Pfizer-associated assays at external CROs supporting VRD programs. Responsibilities include transfer of biofunctional, ligand-binding, serological, and diagnostic assays to CROs as well as oversight of staff training, assay documentation, and scientific and organizational leadership to the CRO leadership. Maintain a 12-month master testing schedule and provide financial guidance for outsourced activities. Routinely monitor assay performance at CROs. Actively contribute to assay investigations and problem solving that arise in routine and non-routine assay testing. 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 the 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 relationship with contract laboratories. Independently performs all aspects of work to support clinical and development studies with minimal support from direct supervisor. Effectively communicates experimental design, strategy and results verbally and in writing. Authors, reviews, and approves standard

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