Associate Director, Cell Culture Process Development (Shanghai/Wuxi, China)
Lead tech transfer activities and provide on-site and on-floor cell culture support for the cGMP facility in Wuxi city;
Develop & optimize cell culture processes for IND-enabling projects per China/US/EU regulatory requirements;
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.
PhD degree and at least 4 years industry experience, or MS degree and at least 8 years industry experience.
He/she must have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have li expertise in process optimization, scale-up and technology transfer.
Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is a plus.