Associate Director/Director, Upstream Manufacturing/Downstream Purification
- Supervise daily downstream/upstream 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 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 strong 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 production groups and other functional groups to meet the production objectives and timelines.
- BS/MS in a scientific discipline or equivalent is preferred.
- Minimum 6-15 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 (For Downstream)
- Experience in mammalian cell culture, from cell expansion to large scale bioreactor production (For upstream)
- Must be a strong 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.
Job Function: Research & Development
Primary Location: China-Shanghai