职位描述
This is a newly created position that will lead the cell culture process development (CCPD) group in Wuxi city.The group is being setup with the following main responsibilities:1. To lead tech transfer activities and provide on-site and on-floor cell culture support for the cGMP facility in Wuxi city;2. To develop & optimize cell culture processes for IND-enabling projects per China/US/EU regulatory requirements;3. To develop & optimize late-stage (Phase II/III) cell culture processes, including design and execution of process characterization and validation studies. Key aspects of the position include hiring/coaching/mentoring and managing junior staff members; technical oversight of study design, execution and results interpretation; interaction with manufacturing groups and development groups in Shanghai; and managing budgets etc.Qualifications:1. The candidate should have a PhD degree and at least 6 years industry experience, or MS degree and at least 10 years industry experience.2. He/she must have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in process optimization, scale-up and technology transfer.3. Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is a plus.The position is based in Wuxi city.
