1. Leader in cell technology development, Responsible for transforming research and development into industrialization.
2. Supervise daily upstream/downstream manufacturing activities and ensure production timelines are met.
3. Collaborate with Process Development and Project Management groups technical transfer and process validation
4. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation.
5. Provides working knowledge and technical leadership in cell culture/purification operations.
6. Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
7. Contributes to continual improvement of all manufacturing documentation (SOP, SMP) to ensure they are current, accurate, and clear.
8. Communicate operational status regularly to CEO, as required, at the appropriate level of detail.
1. PhD in cell engineering, cell biology, immunology is preferred.
2. Working experience in cell therapy companies is preferred.
3. 5-10 years working in cell engineering with previous experience managing subordinates and/or leading project teams.
4. Minimum 2 years working in a cGMP biological manufacturing environment.
5. Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
6. Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
7. Experience in working with the cross-functional teams.
8. Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
9. Must possess good interpersonal skills and the ability to communicate well, both verbally and written. Fluent in both Chinese and English.
联 系 人：人力资源部