- $101,200.00 -151,450.00/year*
118 Church St
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. JOB RESPONSIBILITIES
QUALIFICATIONS / SKILLS
- 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)
- 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.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. 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.
1 (First Shift) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Associated topics: aseptic, biopharmaceutical, food, histology, immunology, nutrition, physiologist, physiology, toxicologist, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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