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This position is within the Reagents area of the High Throughput Clinical Testing (HTCT) group of Clinical Testing & Business Operations within VRD. The incumbent will oversee critical reagent identification and qualification for biofunctional and ligand-binding assays supporting various vaccine development projects. In addition, the incumbent will work with the clinical throughput manager(s), project PI(s) and the head of Reagents to plan and prioritize and coordinate reagent qualification, as well as forecast resources for these tasks, in order to meet business timelines. The incumbent will be technical expert in critical reagent qualification and will perform critical data review of critical reagent qualifications. In addition, the incumbent will lead/initiate investigations of assays that perform out of specification, especially when critical reagents may play a role.
Be a technical expert of several biofunctional and ligand binding assays and a recognized subject matter expert for reagent performance in cross-functional and program teams. Presents updates of reagent qualification and assay troubleshooting in HTCT, cross-functional and program team meetings. Develop and execute reagent qualification studies. Monitor reagent performance during clinical throughput, and initiates investigations. Participate in assays qualification and validations, establishing baseline reagent performance. Source reagents from vendors or in-house materials. Identifies additional vendors, as needed. Participates in evaluation of custom materials prepared under contract. Coordinate with other senior managers, project PI(s), heads of BFA and LBI teams and/or contract laboratories to plan/schedule reagent evaluations. Provide project related instructions as needed. Presents experimental results at group meetings, project meetings and department meetings. Manage a team of 3 5 direct reports and provide managerial guidance. Prepare and revise documents associated with reagent qualifications, including test methods, operating procedures, technical reports and regulatory documents, as needed. Attend corporate and departmental training, as available. Satisfactorily completes all cGLP, safety and other assigned training in conformance with job/departmental requirements.
Ability to perform work while standing/sitting.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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Other Job Details:
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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