JOB SUMMARY Works closely with other Pfizer biomarker scientists to identify clinically significant biochemical markers and develop/adapt biomarker assays for routine use in clinical trial setting. Responsible for running biomarker assays primarily to support clinical trials in New Haven CRU and external clinical studies.
Design and develop assay formats, select techniques, and optimize conditions for biomarker assays.
Conduct assay performance evaluation and validation.
Perform biomarker assays to support studies in New Haven CRU and external protocols as needed.
Involved in study design of sample collection and processing.Includes contribution to and review of clinical protocols, interaction with study teams and/or the Clinical Assay Group (CAG) to identify problems or concerns in pending studies, and managing resources to most efficiently support scheduled studies.
Provide budget estimate, timelines, and metrics for biomarker assays.
Acquire skills in new methods, instruments, and technologies.
Organize and maintain Biomarker laboratory, including cleanliness, safety, supplies and documentation.Monitors and disposes chemicals and reagents that are expired or no longer required.
Perform all quality control checks on instruments and biomarker assays.
Maintain quality control and calibration records.
Responsible for overseeing maintenance of laboratory equipment and documentation.
Independently plan and execute experiments.
Update the Operations Director on the status, results and problems in method development and performance of the assays.
Analyze, summarize, and document experimental results.
Write SOPs, validation,plans and reports, study plans and reports.
Supervise, provide guidance and instruct laboratory personnel.
May provide assistance to the staff in the Clinical Safety Lab in assay evaluation and validation and trouble-shooting.
Perform data entry and monitor Laboratory Information System (LIS) and Phase I Management System (PIMS)
QUALIFICATIONS / SKILLS
Bachelor's degree in Biological or Chemical Sciences with 15 plus years of experience required; Masters degree in Biological or Chemical Sciences with 10 plus years of experience required; Ph. D. degree in Biochemistry, Immunochemistry, Protein Chemistry or Molecular Biology with 7 yrs experience is desired.
Solid background and extensive experience with development and validation of most of the common biochemical (ELISA, analytical , cell based (proliferation, cytotoxicity), and flow cytometry assays. Experience with automated clinical laboratory analyzers (Clinical Chemistry, Hematology, Immunoassay) is desired.
Thorough understanding and demonstrated proficiency in development of analytical methodologies (e.g., capture immunoassay, flow cytometry, cell function and cell based assays, ex vivo assays, /EIA).
Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
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