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This position is within the Cell Culture area of the High Throughput Clinical Testing (HTCT) group within VRD. The incumbent is responsible for oversight of the cell and reagent supply required for regulated assay throughput, including of the preparation of relevant regulated documents. The incumbent will serve as a subject matter expert on cell culture operations and interact with colleagues in cross-functional teams. This will include, but not limited to, devising plans to ensure an adequate cell supply for assays, resource forcasting, scheduling and prioritization of requests from various vaccine programs, adequate reagent supply and qualifications, troubleshooting/investigations/trending, monitoring cell performance, and attending and participating in various (sub)teams. The incumbent will lead investigations for process problems and troubleshooting, and conceives/promotes novel experimental approaches to cell culture operations. This position reports to the head of cell culture. The position also involves performing other tasks as assigned, related to HTCT functional bioassays. All of the above includes practicing laboratory safety at all times and efforts toward cGMP compliance. The incumbent must have excellent writing skills, as writing standard operating procedures and reports are an essential component of this position. As an integral member of this dynamic team, the incumbent must have a strong, positive work ethic and be highly collaborative with the other group members.
Strategizes and oversees the day-to-day cell culture operations, including leading a cell culture subteam and approximately 6 direct reports, supporting early and late phases of vaccine clinical development studies. Subject matter expert for cell culture, especially undifferentiated & differentiated HL60 cells and associated flow cytometry. Designs and manages cell culture experimental processes and qualification / bridging studies, in consultation with the head of cell culture, as appropriate. Collaborates withAssay Development colleagues in these endeavors, as appropriate. Authors, reviews and/or oversees the preparation of regulated and unregulated cell culture documents and technical reports, equipment qualification and SOPs. Acts as a liaison with Assay Development and Research groups to plan and coordinate delivery of an supply of cells. Provides scientific and organizational leadership through strong interpersonal skills. Identifies and leads investigations for process problems and suggests/evaluates resolutions and improvements. With limited or no guidance from the supervisor, the incumbent performs complex tasks and discusses conclusions on the results obtained at group and project meetings, as needed. Manages and oversees the training of junior colleagues on new and established technologies. Proposes and promotes the implementation of novel/innovative experimental approaches for new or existing cell culture projects, if appropriate, in consultation with the supervisor. Forecasts timelines and cell cullture resources to support vaccine programs, and communicates these to relevant internal and external teams, as appropriate. Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.Satisfactorily complete all cGMP/GLP and safety training in conformance with Departmental requirements. Perform other duties as assigned.
EDUCATION AND EXPERIENCE
PhD with 0-3 years relevant experience (cell culture, immunology, cell biology, microbiology, or virology)
TECHNICAL SKILLS REQUIREMENTS
A strong background in a biological science is essential. At least 0-3 years of relevant academic, pharmaceutical, or biotechnology laboratory experience is necessary. Ability to manage time and be organized is a must for the job. The incumbent must have the ability to handle changes in a project direction or performing unexpected urgent assignments. The incumbent must conduct complex experiments, perform calculations, and discuss conclusions regarding progress and results of work. The incumbent designs experiments and suggests improvements to existing methodology. The incumbent needs to ensure that the methodologies are compliant with GLP and regulatory standards before utilization. The incumbent must take the initiative, be self-motivated, and display independent
Proficiency in the use of word processing, Excel, PowerPoint and relevant scientific software is desirable. Excellent verbal and written communication skills are required.
Prior cell culture experience and flow cytometry is strongly preferred.
Work primarily performed in the laboratory and at individuals desk using a computer. Lifting not more than 8-10 pounds required. Walking to various laboratories/biosuites. This position requires the ability to stand and reach inside the hardware environment of various laboratory robotic equipment, and lift and transport robotic components to and from the laboratory bench. This position may require occasional weekend work to meet critical timelines.
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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