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 $