Pfizer DSRD Biomarker Global Clinical Pathology/Biomarker Operations Senior Associate Scientist in San Diego, California
This position will reside within the Global Clinical Pathology laboratory a section of the Global Biomarker Laboratories within Drug Safety Research and Development The candidate will contribute to the Global DSRD Biomarker Clinical Pathology group to enable effectiveness across the DSRD Global Biomarker organization.
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 regulatory standards as applicable within a clinical pathology laboratory.
Other responsibilities of the candidate will include ensuring the quality of raw data, contributing to methodology development for new biomarkers, contributing to technology development, and writing of SOPs and validation reports where appropriate. Exposure to new methods development such as flow cytometry, plate base assays are possible but will depend upon individual experience.
Knowledge and experience with a laboratory informatics data collection system. Candidate may develop/validate new methodologies or applications, process and evaluate data from samples or specimens provided from others or for multi-site studies, evaluates 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 assures that laboratory activities meet quality standards such as Pfizer policies, SOPs, Environmental Health and Safety and departmental guidelines.
Relevant laboratory experience and knowledge of biology that could be demonstrated through:
B.S./B.A. in medical technology or related field, with 2-5 years relevant experience in the Hematology discipline
Associates Degree in medical technology or related field, with at least 2 years relevant experience
ASCP certified is preferred, but a candidate with strong biology skills and a willingness to learn clinical pathology assays will be considered.
Ideally greater than 2 years of experience within a clinical pathology laboratory within a pharmaceutical company, CRO, hospital or diagnostic company with knowledge of Good Laboratory Practices, data collection laboratory informatics systems, and data processing applications.
If the candidate does not possess a medical technology degree, knowledge of physiology and basic chemistry are highly desirable.
OTHER ATTRIBUTES DESIRABLE:
Well organized, self-motivated, detail oriented, and has the ability to work and effectively communicate within a team environment. Candidate assures that laboratory activities meet quality standards such as Pfizer policies, SOPs, Environmental Health and Safety and departmental guidelines, ability to handle multiple projects simultaneously, maintaining a high quality of data and timely delivery of results, 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 be passionate about work.
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.
Eligible for Employee Referral Bonus
Pfizer US Exempt Grade 4
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