Responsibilities:

• Participate in interaction with manufacturers to garner product ideas
• Draft technical strategic plans
• Work with directors to define critical product specifications and requirements
• Will need to lead a diverse technical team for process development
• Lead the process development team to outline timelines, work plans and milestones for deliverables.
• Technical review of all manufacturing and product development data; and identify any potential obstacles for success.
• Work with management to define product costs, quality costs, commercial scale availability, and applicable cost of goods.
• Work with management to facilitate new products development
• Author and review technical documents including standard operating procedures, testing protocols, technical reports, work instructions, master batch records, and technical transfer documents
• Support the scale up and development of research-based processes in accordance to regulatory and cGMP guidelines for cell therapies.

Minimum requirements

• Minimum PhD in Biopharmaceutical, Pharmaceutical Technology & production, Chemical engineering, Pharmacy or other relevant Life Science-related postgraduate degrees.
• 3 – 5 years’ supervisor/management experience preferred.  At least 1-2 years of experience in cGMP cell culture required, with cell therapy manufacturing highly desirable.
• Previous experience in management of cell therapy CMOs is a plus.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus
• Previous tech transfer experience is a plus.
• Adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of process data.
• Conduct investigations in support of manufacturing issues and provide technical oversight for investigations, change control, equipment qualification, and aseptic process validations
• Strong Presentation & Public Speaking Skills

香港中基1號國際醫療集團是世界膝關節健康行業領導者，是以膝關節健康為核心，集研發、生產、銷售、治療、服務、投資為一體的產融結合生態型企業，致力於讓人類生命延長10年。旗下兩大世界領先國際醫療機構：中國國際膝關節醫療中心及中國國際抗衰中心。