The Regulated Clinical Biomarker/Flow Cytometry group works with clinical and translational teams across research units to develop and implement complex flow cytometry-based biomarker assays and supportive translational/mechanistic studies for early phase clinical projects in a GCLP environment. 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 clinical biomarker studies supporting drug candidates. This scientist will interact with inter-departmental colleagues, clinical and translational teams, research units and contract research organizations in a matrixed environment.
Job Responsibilities
Responsible for clinical flow cytometry biomarker assay development and validation, data generation and analysis, QC, data interpretation and communication to project teams to enable appropriate decision making.
This position will participate with ECD 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 clinical studies, and have strong knowledge of biological systems, cellular functions and concepts in immunology to enable discovery and development objectives.
Responsible for developing partnerships in a matrix environment, influencing project strategies, 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 study execution including all proscribed training as found in ECD SOPs and training transcripts. This includes knowledge, training and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting 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 collogues 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.
Occasional weekend work for processing clinical samples should be anticipated.