Associate Director/Director, Downstream Development
- 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.
- 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.
Primary Location: China –Shanghai
To apply please send your application to HR_Biologics@wuxiapptec.com