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• This position is responsible for execution of scientific research and/or scientific strategies in a biomarker/biomeasure focused flow cytometry laboratory. This scientist will provide technical and scientific support for biomarker data using flow cytometry (FACs), cell imaging and related technologies for both non-regulated and regulated preclinical and clinical biomarker studies supporting Pharmaceutical drug candidates.
• Responsible for providing flow cytometry and cellular imaging data for biomarker/biomeasure discovery and development, supporting assay method development, validation and study execution.
• This position will participate with PDM teams and research units in a matrix environment. The person will demonstrate experience in the delivery of flow cytometry and cell imaging-based biomarkers/biomeasures in animal and clinical studies, and have strong knowledge of biological systems, cellular functions and concepts in immunology to enable Pharmaceutical discovery and development objectives.
• Responsible for developing partnerships in a matrix environment and providing expertise in technology development and implementation.
• This role will participate in all phases of FACs laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
• All colleagues in this role are responsible for maintaining regulatory compliance appropriate for clinical and preclinical study execution including all proscribed training as found in PDM SOPs and training transcripts. This includes knowledge, training and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting Pharmaceutical portfolio projects as applicable.
• Participate in continuous improvement of scientific and regulatory processes via update/creation of SOP’s, design and implementation of laboratory and study based processes, and development of best practices for bioanalytical data generation.
• Responsible for QC and peer review of raw data, results, and final reports from other colleagues within the regulated group (depending on level of training). Additionally responsible for participation in internal and external audits providing required information to auditors as needed. May also participate/respond to internal audit findings on assigned projects.
• Knowledge and training on the use of PDM flow cytometry and related platforms including appropriate use of software systems, EworkBook application and use, and data transmission policies, procedures and practices.
• Understanding of basic principles of flow cytometry, cell base imaging analysis, cellular biology and fundamental concepts of immune-analytical sciences as relates to flow cytometry based methodologies
• Excellent oral/written communication skills, providing proactive communications with all relevant partners on Pharmaceutical projects.
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