Director/Senior Director, cGMP Commercial Manufacturing Operations
- Participate in the detailed design and construction of Biologics Phase III cGMP commercial manufacturing facilities in Wuxi city
- Co-lead the commissioning and qualification of the Facilities
- Lead the operations management of manufacturing activities
- Support the design, construction, commissioning and qualification of GMP/non-GMP facilities in Shanghai.
- Ensures that facility design, construction, commissioning and validation comply with appropriate regulatory requirement and construction code.
- Ensure the manufacturing operations comply with cGMP requirement, requirement in timeline, cost control and energy efficiency
- Ensures Management is well informed on progress of the Facility and status of manufacturing.
- Assist in strategic planning for DS and DP facility expansion.
- LSS of the Facilities
- Responsible for managing manufacturing operations in the Facilities
- As project team member, responsible for supervision of construction of the Facilities
- As project team member, responsible for commissioning of the Facilities
- Responsible for EHS management of the Facilities
- Bachelor and above degree in pharmaceutics, biology, engineering, business administration
- More than 10 years of manufacturing operations management / facility management in pharmaceutical and biopharmaceutical facilities
- Good knowledge and hands on experience in lean manufacturing
- Good knowledge and experience in GMP environment and working within Quality System
- Good knowledge and experience in project management
- Hands experience of leading manufacturing team of more than 200 people
- Good communications skill
- Fluent in written and verbal English communication
Job Function: Research & Development
Primary Location: China-Shanghai