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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

Basic Qualifications:

  • 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