1. Cooperate with QA, engineering and procurement departments to complete equipment procurement and validation;
2. Be responsible for cell culture process and manufacturing in pilot scale or commercial scale;
3. Participate in the creation or update of SOP/MBR and the final review of batch execution records;
4. Assisted in the implementation of technology transfer, and completed process confirmation on the company's GMP manufacturing platform;
5. Responsible for dealing with daily affairs of the production site, participating in maintaining, improving and improving the production system and GMP system, and ensuring the strict implementation of various systems and documents;
6. Responsible for the daily management and training of subordinates, guiding them in their daily work and assisting them to improve their working skills;
7. Maintain a safe environment in the cGMP plant;
8. Other duties to be assigned.
1. Bachelor degree or above in biochemistry, biological engineering and fermentation engineering. More than 5 years cell culture working experience is preferred;
2. Proficient in upstream unit operations such as cell passage amplification, bioreactor culture and harvest clarification, and familiar with disposable products;
3. Have relevant knowledge or experience in cell culture GMP production, more than 3 years working experience in biopharmaceutical GMP workshop, including more than 1 year of production management experience;
4. Strong communication skills, clear thinking, self-motivated and responsible;
5. Good team spirit;
6. Cet-4 or above, with a certain ability to read and understand English documents.