This position will reside within the Groton Clinical Pathology laboratory a section of Safety Biomarkers and Translational Sciences within Drug Safety Research and Development. The candidate will contribute to the DSRD Clinical Pathology group to enable effectiveness across the DSRD Global Biomarker organization. The role will provide laboratory support for the Clinical Pathology laboratory including routine Clinical Pathology and investigative biomarker support to support both efficacy and safety evaluation of drug candidates for discovery, pre-clinical, and clinical studies. Routine clinical pathology analysis involves hematology, clinical chemistry, coagulation, immunoassay and urinalysis.
ROLE RESPONSIBILITIES The major duties & responsibilities will include but are not limited to:
The candidate is responsible for generation of hematology, clinical chemistry, urinalysis, coagulation, immunoassay, and novel assay development data in support of both safety and efficacy assessment of pharmaceutical drug candidates in compliance with GLP/GCLP regulatory standards as applicable within a Clinical Pathology laboratory.
Other responsibilities of the candidate will include ensuring the generation of the highest quality of Clinical Pathology raw data, contributing to methodology development for new biomarkers, contributing to technology development, author technical documents such as validation plans and summaries, Standard Operating Procedures (SOPs), User Guides where appropriate.
Exposure to new methods development such as flow cytometry and plate base assays is possible based upon individual experience and knowledge.
Experience with a laboratory informatics data collection system is required.
Candidate may develop/validate new methodologies or applications, process and evaluate data from samples for multi-site studies, evaluate data including 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.
The candidate contributes to biomarker assay validation, including planning, data collection, interpretation, and document authorship to support GLP and non-GLP multispecies safety studies.
The candidate assures that laboratory activities meet quality standards such as Pfizer policies, SOPs, Environmental Health and Safety and departmental guidelines.
B.S. /B.A. in Medical Technology/Clinical Laboratory Science or related science related field with 2-5 years of experience within a Clinical Pathology laboratory in a hospital or diagnostic company, pharmaceutical company, or CRO; with knowledge of Good Laboratory Practices, data collection laboratory informatics systems, and data processing applications
Candidate assures that Clinical Pathology laboratory activities meet quality standards such as Pfizer policies, Standard Operating Procedures, Environmental Health and Safety and departmental guidelines
Candidate has the ability to handle multiple projects simultaneously, delivering high quality of Clinical Pathology data meeting all established timelines.
Well organized, self-motivated, detail oriented, and has the ability to work and effectively communicate within a team environment
Excellent oral and written communication skills and ability to multitask, and highly motivated and enthusiastic scientist with proven record of independent analytical thinking and collaboration, ability to relish change, energize others and are passionate about work and have experience with Cerner laboratory information system and laboratory based workflows.
Thorough understanding of the processes associated with pre-clinical and clinical study coordination and data management
Knowledge of multiple scientific disciplines that allow the collaboration with other sections such as Immunotoxicology, general toxicology, safety pharmacology, investigative toxicology or other disciplines
Ability to handle multiple projects simultaneously, maintaining a high quality of data and timely delivery of results
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 up to 40lbs (on occasion), pipetting and other general lab tasks as required by the position are required.
Internal Number: 4812015
Please apply directly on our careers site: careers.pfizer.com