Pfizer Scientist, External Laboratory Management in Pearl River, New York
This position is within the External Laboratory and Reagent Management (ELRM) group within High-throughput Clinical Immunoassays & Diagnostics (HCID) within Vaccine Research and 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 coordinate sample testing as well as contractual and documentation obligations supporting VRD programs at external partners including academic institutions, government laboratories, and contract research organizations (CROs). In addition, the incumbent may participate in and contribute to internal technical discussions within the HCID group of VRD. 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 under limited supervision with periodic review of achievements and results but will r eceive instructions primarily on unusual or complex problems. Wor k 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
Takes a significant role in the coordination of clinical sample testing and Pfizer-associated assays across multiple programs at external contract laboratories.
Communicate with external laboratory leaders and managers to ensure the smooth operation of assay throughput and associated activities supporting clinical sample testing.
Oversight and management of documentation such as SOPs, Bioanalysis plans, Work Orders, and Data Agreements to ensure all operations are done in a compliant fashion, in accordance with prevailing SOPs, and GCLP/GLP/GMP regulations, as appropriate. Has a strong working knowledge of HCID processes and compliance as they are described in detail at the SOP level.
Act as a liaison between Pfizer testing groups and the external laboratory to coordinate activities and ensure the needs of Pfizer are addressed.
Independently performs all aspects of work to support clinical and development studies and assists in the generation and collection of data to support vaccine clinical trials. May provide critical data review of clinical and non-clinical data.
Routinely monitor the progress of testing to ensure that Pfizer business timelines are met. Effectively troubleshoot problems that may arise in routine and non-routine assay/equipment processes.
Understands and has a strong working knowledge of the critical data systems (from an end-user perspective) that support HCID.
May present experimental results at departmental meetings.
Attend Power2Learn, corporate, and departmental training, as available.
Satisfactorily complete all GCLP/GLP/GMP and safety training in conformance with VRD & HCID requirements. Where applicable, performs job responsibilities in compliance with GCLP/GLP/GMP and all other regulatory agency requirements.
Performs other tasks as assigned.
BS or MS in microbiology, immunology, virology, biochemistry or related discipline with 2 years (MS) or 4 years (BS) relevant experience, preferably in an industrial setting.
Ability to multitask project objectives, understand goals and their priorities as well as demonstrate problem solving skills in the planning and execution of experiments.
Excellent verbal and written communication skills.
Ability to work independently and as part of a team.
Excellent organization and planning skills, the ability to work in a fast-paced environment with strong motivation, work ethics and attention to detail.
Proficiency in Microsoft Office 365 applications and relevant scientific software.
Experience in the execution of clinical testing in support of clinical trials is desired.
Direct hands-on experience working in a regulated (GCLP/GLP/GMP) environment is preferred but not required.
Strong attention to detail and commitment to operational excellence.
The ability to effectively design and execute laboratory experiments and communicating results both verbally and in writing is required.
Ability to perform work while standing/sitting.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This position may require weekend and evening work to meet critical business timelines.
This position may require occasional travel to scientific meetings, between Pfizer sites, to CROs, and other business-related travel.
Other Job Details:
Eligible for employee referral programs: YES
Eligible for relocation support: YES
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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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