Global Clinical Pathology Scientist

4 ROLE SUMMARY

The Clinical Pathology Laboratory scientist within the Drug Safety Research and Development Global Pathology group provides routine clinical pathology and biomarker discovery/development support for both efficacy and safety evaluation of drug candidates for discovery and pre-clinical toxicology studies. The Clinical Pathology scientist is responsible for generation of hematology, clinical chemistry, urinalysis, coagulation, immunoassay, flow cytometry, novel assay, novel platform development data in support of the safety assessment of pharmaceutical drug candidates in compliance with GLP regulatory standards as applicable within a DSRD Clinical Pathology Laboratory.

ROLE RESPONSIBILITIES

• Generates and ensures the delivery of the highest quality of Clinical Pathology/ Biomarker study data for both internal DSRD/RU and external multi-site studies.

• Reviews and evaluates Hematology, Coagulation, Clinical Chemistry, Urinalysis and Immunoassay data, processes and analyzes study samples and quality control samples, participates in routine equipment maintenance and instrument and/or assay troubleshooting, provides data collation, summarization, QC evaluation, and archiving as required.

• Reviews and evaluates Clinical Pathology and biomarker data from samples from multi-site studies

• Authors technical documents such as validation plans/reports, qualification plans/reports, SOPs, User Guides, Reference Cards, and memos as required.

• Performs and contributes to methodology development and biomarker assay validation, including planning, data collection, interpretation, and document authorship to support GLP and non-GLP multispecies safety studies as well as Pfizer human clinical trials where applicable.

• Assures that laboratory activities meet quality standards such as Pfizer policies, SOPs, Environmental Health and Safety and departmental guidelines.

• Perform all regulatory responsibilities in compliance with applicable regulatory standards as applicable within a DSRD Clinical Pathology Laboratory

• Collaboration with other sections such as, Safety Sciences, Global Pathology, Comparative Medicine and other disciplines.

• Supports multiple projects simultaneously, maintaining a high quality of data and timely delivery of results

• Collaborates with Regulatory Quality Assurance, DSRD management, study directors to address audit concerns

• Maintains the Clinical Pathology laboratory in an Inspection Ready status

• Potential exposure to new methods development such as flow cytometry and plate base assays if possible based upon individual experience and knowledge.

Technical Skills Requirements:

• Specimen processing and performs routine and specialized laboratory testing routine and specialized tests in areas such as: Hematology, Clinical Chemistry, Coagulation, Urinalysis, Immunoassay

• Operates, calibrates, and maintains automated analyzers and laboratory equipment, conducts QC procedures, monitors results, and troubleshoots discrepancies, interprets test results, enters data into Laboratory Information Systems (LIS)

• Adheres to and follows all Pfizer procedures, policies, SOPs and protocols aligned with FDA, OSHA, and all other applicable regulatory standards.

QUALIFICATIONS

Must Have

• BS or BA in Clinical Laboratory Science, biology or related field with 6 to 8 years of related experience in a Clinical Pathology laboratory, hospital clinical laboratory, pharmaceutical company, CRC or diagnostic company OR MA with 4 to 6 years of related experience in a Clinical Pathology laboratory, hospital clinical laboratory, pharmaceutical company, CRO, or diagnostic company

• American Society of Clinical Pathology Board of Registry Medical Laboratory Scientist ASCP (MT, MLT, CLS or MLS)

Nice to Have

• Knowledge of Good Laboratory Practices (GLP) regulations

• Strong attention to detail, organizational skills, and ability to work independently or as part of a team.

• Proficiency with laboratory equipment and LIS software

PHYSICAL/MENTAL REQUIREMENTS

• The position requires performing a range of laboratory work and therefore the colleagues must be able to wear appropriate PPE and physically perform the technical procedures required. Standing, sitting, lifting to 40lbs (on occasion), pipetting and other general lab tasks as required by the position are required.

Other Job Details

• Work Location Assignment: On Premise

The annual base salary for this position ranges from $77,100.00 to $128,500.00. In addition, this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

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 providers 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. This position requires permanent work authorization in the United States.

Research and Development