CMC Product Manager
Job Responsibilities:
1. In charge of the technology transfer of cell therapy products, and complete the production smoothly;
2. Responsible for establishing SOP Technical Management Operation Procedure;
3. In charge of clinical application preparation/GMP production;
4. Make production plan, organize production, ensure production on time, quality, quantity and safety;
5. Organize production team to carry out production, collect and analyze production data, deal with deviation and abnormal situation in production process in time, and formulate corresponding preventive and corrective measures;
6. Participate in the preparation of company IND documents and related technical support;
7. Identify recruitment needs according to business needs, interview production staff and Build Team;
8. Develop training, teaching, assessment plan, the implementation of training, teaching, assessment of line subordinates to ensure that staff can meet the needs of the post; 9.the company's other work arrangements.
Qualifications:
1. Bachelor degree or above, Major in biology, at least ;
2. 5 years experience in cell therapy product development and production, at least 3 years management experience;
3. Experience in preparation of cell therapy clinical preparations/GMP production;
4. Good communication skills, management skills, team work and production and execution skills;
5. Have a good spirit of cooperation, serious, responsible, a certain degree of English reading ability.