職位描述
Downstream Process Development is responsible for purification process development, purification technology development, process scale-up, technical transfer and support for pre-clinical and clinical manufacturing of biologics derived from mammalian cell cultures. The scope of downstream process development includes cell culture clarification (centrifuge and depth filtration), column chromatography, viral inactivation/removal, and ultrafiltration/diafiltration.Responsibilities:1. Design the downstream processes that are efficient, robust and scalable for the clinical manufacturing.2. Assist the Sr. director to coordinate the work between the downstream development group and other functional groups to meet the project objectives and timelines.3. Oversee the process scale-up and technology transfer activities between the process development team and manufacturing team.4. Coach the group leads and staff on the process development and validation.5. Establish the robust purification development and scale-up platform.Basic Qualifications:1. MS with 10+ years, or PhD with 6+ years downstream process development experience.2. People management experience preferred3. Experience in developing the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal4. Experience in working with the cross-functional teams.5. Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.The position is based in Shanghai or Wuxi city, China
