The Gene Transfer Facility quality system ensures compliance of the facility with cGMP and governs manufacturing and testing requires excellent data management to allow traceability and analysis. This is a prerequisite for auditing, addressing non-conformance and quality improvement. Data analysis and correlative studies also contribute to the quality improvement approach by laying the cornerstone for assay revision and implementation of new technologies.
The QC Supervisor is responsible for planning QC activities in the CTCEF lab including developing new assays, SOPS, preparing data reports, infusion, and validation. The role is responsible for the direct management and supervision of QC technicians in the lab.
Direct supervision and Staff Management of CTCEF QC Technicians
Organizes routine QC bench works
Liaise with project manager to coordinates the development of new QC assays
Attends research development and project management meetings
Elaborate a plan to develop new assays (time and material)
Support the Testing and Analytical Manager to verify the completion of MPCR QC log, issue Cellular products certificate of analysis, and troubleshoot assay failure
Prepare validation reports for new assays
Write SOP for new assays
Masters degree in Science with 4-7 years of experience in a clinical laboratory or in a controlled therapeutic manufacturing environments is highly preferred
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.