Director, Biologics Process Development (Large-Scale Production from Mammalian Cell Culture)
Director of Biologics Process Development is responsible for the large-scale production of biologics from mammalian cell culture, the cell culture production process control and its optimization following cGMP requirements. He or She is also responsible for production data review, analysis and cGMP internal audits and corrections.
· Responsible for scale-up of biologics and technical transfer of large-scale production process.
· Responsible for construction of manufacturing facility, creation of production data, data review, and data analysis.
· Responsible for process control of cell culture production and its continuous improvement.
· Responsible for ensuring all production processes in compliance with cGMP requirements, involving in the internal audits and deviation investigations, and developing corrective and preventive actions (CAPAs) to improve implementations.
· Bachelor’s degree or higher in cell biology, bio-engineering, bio-pharmaceutical and other related fields.
· Ability to communicate in Mandarin.
· A minimum of 5 years of experience in large scale mammalian cell culture production.
· Experience in cell culture with 2000L bioreactors and above, with hands-on experience in production or cGMP verification.
· Familiar with recombinant protein drugs and hands-on experience in cGMP facility design and operation.
· Experience in large-scale production of recombinant proteins/antibodies from CHO cells and quality management.
· Experience in production team management.
· Familiar with cGMP regulations.