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Associate Director, Downstream Development (Shanghai/Wuxi, China)

Key Accountibilities:

  • Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.
  • Assist the director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.
  • Oversee the process scale-up and technology transfer between the process development team and manufacturing team.
  • Coach the group leads and staff on the process development and validation.
  • Manage the activities for the validation of the downstream processes.
  • Requirements:

  • MS with 12+ years, or PhD with 8+ years downstream process development experience.
  • At least 4 years’ people management experience
  • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
  • Experience in downstream process cGMP production.
  • Experience in downstream process validation
  • Experience in working with the cross-functional teams.
  • Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
  • Experience in regulatory submission to FDA/EMA.