Functioned with multiple departments, including planning, quality, and warehouse verified all tasks associated with the manufacture of commercial products following batch records and standard operating procedures to ensure safe and compliant operationsSupported the manufacturing process of the CAR-T cell therapy in compliance with safety policies, quality systems, and cGMP requirements; worked as part of a team to execute GMP runs in close collaboration with materials management, quality control, and quality assurance.Successfully raised processing and equipment issues promptly to manufacturing management and involved in troubleshooting; supported the development of manufacturing processes and worked with others to drive continuous improvements and efficiencies within cell therapy Technical OperationsAccomplished batch production records under cGMP and documents in detail through the use of SOPs and BPRs for the processes and manufacturing stepsCooperated with the Process Development & Manufacturing Sciences and Technology group to transfer new projects into GMP.Responsible for analyzing efficiency and performance, looking for continuous improvement, and assessing the group's performance against various measures to determine successful implementation. Regularly scrutinized the efficiency of procedures according to organizational objectives and implemented improvements.

 Prepared and implemented quality assurance policies and procedures; carried routine inspections and quality tests. Assessed and resolved workflow and production issues, ensuring that standards and safety regulations were observed. Addressed and discussed issues and proposed solutions with superiors. Documented quality assurance activities and creating audit reports; developed training materials and operating manuals.