Be responsible for the research, development, optimization and transfer of process technology for cell therapy products of the Company
Be responsible for establishing and improving the CMC lab-scale process development platform for cell therapy products of the Company, including the establishment of cell bank, preparation of cell therapy products and improvement of processes.
Organize the department to formulate and abide by relevant operating procedures and management procedures, and organize to review technical reports for quality assurance;
Cooperate with QA Department, QC Department, Project Management Department, Registration Department and other departments to complete relevant works;
Provide professional decisions and suggestions to the pilot-scale platform built by the Company for cell therapy products;
Coordinate with external CDMO company for process development, pilot-scale process transfer and process verification, and supervise the CMC project progress and quality of CDMO company;
Assist in the preparation of application documents, and the communication with NMPA, National Health Commission and other regulatory authorities.
Master degree or above in microbiology, cell biology, immunology, biochemistry and other related disciplines, with more than 5 years of experience in the production and process development of cell therapy products; familiar with the overall process of production and development of cell therapy products, with valuable insights and practical experience in the establishment of cell banks, cell differentiation, culture process, sterile preparation process, etc.;
Familiar with FDA, ICH, other relevant guidelines and Good Manufacturing Practice;
People who are experienced in immune cell culture technology, process study and development are preferred;
People who are experienced in the construction of cell production workshop are preferred;
With good sense of team spirit, capable in team leading, cross-department communication and organization, and able to work under great pressure; strong in execution and sense of responsibility, good at communication, proactive in works and skilled in organization, coordination and leading;
Excellent oral and written communication skills in Chinese and English; proficient in reading professional literatures and writing documents;