Sr. Director / Director of Purification Process Development Dept.
Main responsibilities include:
·Lead a team of scientists /engineers and associates to develop, scale-up and transfer purification processes from small scale to production scale for therapeutic proteins, antibodies and ADC drugs.
·Develop and optimize the purification processes to achieve higher purity, yield and robustness.
·Design, execute and supervise purification process development programs.
·Perform technology transfer and scale-up activities seamlessly from lab-scale to large-scale production.
·Assist the purification team to perform virus clearance study.
·Support pilot and large-scale production technically and solve technical issues.
·Have good communication skills with ******s in written and oral formats.
·Write and review technical reports and regulatory submission files.
·Manage multiple projects as project leaders in parallel with different priorities.
·Assist BD and marketing teams to acquire new projects.
·Day-to-day team operation management.
Requirement:
·Ph.D. degree in biochemical engineering, cell biology, biochemistry, molecular biology, or other related fields is required.
· A minimum of 10 years of working experience in biopharmaceutical development environment with good track record in purification process development is required. Experiences in international biotechnology companies are preferred.
·Extensive experiences on antibody, recombinant proteins / enzymes and ADC development at small and pilot scale, including but not limited to major aspects of unit operations in chromatography, TFF or ADC conjugation at bench-top and pilot scale, etc.
·Highly experienced in assessing, communicating and streamlining technology and process transfer between development and manufacturing. Process development or manufacture experience with commercial biopharmaceutical products is a big plus.
·Excellent troubleshooting skill is needed.
·Experience with ADC conjugation and purification is a great plus.
·Has leadership vision, with good management,team building and results driven skills.
·Fluent communication in both English and Chinese.
·Good experience in regulatory submission for NMPA, FDA, and EMA is preferred.