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Director of Bio-Manufacturing (Shanghai/Wuxi, China)

Key Accountibilities:

  • Supervise daily upstream/downstream manufacturing activities and ensure production timelines are met.
  • Collaborate with Process Development and Project Management groups technical transfer and process validation
  • Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
  • Provides working knowledge and technical leadership in cell culture/purification operations.
  • Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
  • Motivate, retain, develop existing group members and recruit new staffs to build a li upstream/downstream manufacturing team
  • Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
  • Communicate operational status regularly to senior director, as required, at the appropriate level of detail.
  • Assist the director to coordinate the work between the upstream/downstream groups and other functional groups to meet the production objectives and timelines.
  • Requirements:

  • BS/MS in a scientific discipline or equivalent is preferred.
  • Minimum 6-8 years working in a cGMP biological manufacturing environment with previous experience managing subordinates and/or leading project teams.
  • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
  • Must be a li leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
  • Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
  • 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.
  • Must possess good interpersonal skills and the ability to communicate well, both verbally and written. Fluent in both Chinese and English.
  • Good multi-tasking and prioritization skills.