Flow & Cell-Based Assay Scientist (Clinical Lab Service)

Job Summary： As a member of Central lab team, you will be supporting the start-up of a cell-based assay and flow cytometry analysis. You will help define the requirements for validation and will establish processes under line manager's supervision that will enable the Central lab to operate successfully with regard to the analysis and characterization of cell-based therapies or vaccines; specifically as a flow cytometry scientist. This role provides the opportunity to closely partner with the vaccine development and clinical trials as you define and execute the start-up activities associated with establishing flow cytometry / cell-based assay capabilities and expertise at Central lab. Responsibilities include flow cytometry / cell-based assay method development, validation, qualification, transfer and troubleshooting. In addition, the candidate will be expected to write the validation / analytical protocol and report. Additional responsibilities include validation of computer systems, and management/administration of equipment (e.g. instrument, etc.). General Responsibilities: 1.Collaborate with external groups to identify technology and business processes that will establish flow cytometry / cell-based assay expertise at Central lab. 2.Conduct analysis work following related SOPs and guidance. 3.Review data and evaluate against established acceptance criteria 4.Define requirements for laboratory equipment and support purchasing. 5.Evaluate data to identify trends and/or establish limits 6.Participant in discrepancy investigations and corrective actions 7.Receive and provide training 8.Lead assay development, transfer and validation activities 9.Write, review or approve equipment qualification/maintenance life cycle documents 10.Draft, check, review or approve documents, such as SOP, protocol, analytical result, report and method. 11.Write protocols and reports under limited supervision 12.Assure and apply GCP/CAP throughout operations 13.Participate in CAP/GCP/GLP/ regulatory related training courses. 14.Support internal, external, and regulatory inspections 15.Work to meet schedules, timelines, deadlines 16.Participate in and/or lead projects and process improvements 17.Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. 18.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; manage competing priorities Other tasks assigned by line manager. Clinical Lab Service Scientist 1.Participate in and/or lead projects and process improvements Delegated /assigned as the system owner for computerized system, do the corresponding work for system, such as validation test, periodic review, report, etc. 2.Provide input or set personal performance goals and departmental objectives Establish work priorities to meet targets and timelines; 3.Manage competing priorities Other tasks assigned by line manager.