Responsible for execution of scientific research and/or scientific strategies in a biomarker/biomeasure focused flow cytometry laboratory.
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 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.
Participate with ECD teams and research units in a matrix environment.
Responsible for developing partnerships in a matrix environment and providing expertise in technology development and implementation.
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.
Responsible for maintaining regulatory compliance appropriate for clinical and preclinical study execution including all proscribed training as found in ECD SOPs and training transcripts.
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.
BS with 1+ years full-time work experience with Flow Cytometry or 3+ years full-time research lab experience
MS with 1+ years full-time experience in Fly Cytometry or Research lab experience (Experience should be through work experience only)
Multicolor Flow Cytometry, FACS, FACS Diva, Canto, Fortessa
Knowledge and training on the use of flow cytometry and related platforms including appropriate use of software systems, EworkBook application and use.
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 projects.
Demonstrate experience in the delivery of flow cytometry and cell imaging-based biomarkers/biomeasures in animal and clinical studies
Strong knowledge of biological systems, cellular functions and concepts in immunology to enable discovery and development objectives.
This includes knowledge, training and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting portfolio projects as applicable.