1. Lead Cell Culture group of Process Development, Supervise personnel, and organize/plan resources;
2. Execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing;
3. Make use of sound statistical DOE-based strategy in order to understand deeply the impact of cell culture process parameters on target product quality;
4. Write and review necessary process development related documents including process development reports, technical transfer reports, and characterization and validation protocols and electronic data histories;
5. Write and revise protocols, procedures, reports, batch record and other process related documentation as necessary to support GMP manufacturing operations;
6. Develop employee’s knowledge, understanding, and skills to improve performance and expand abilities;
7. Ensure employees remain current with all department and site training requirement;
8. Taking an active role in incident inquiry, investigation, and reporting;
9. Communicate the group’s status, experiment data and feedback to management in a timely manner;
1. Ph.D. or MS in Chemical/Biochemical Engineering, Biochemistry, Cell Biology, or related discipline with at least 5 years of experience focused on mammalian cell culture process development for the production of therapeutic proteins
2. Familiarity with laboratory procedures and operations including set up and operating shake flasks , lab scale bioreactors and pilot scale disposable bioreactors and associated analytical equipment used for mammalian cell culture processes.
3. Experience with medium selection, process optimization and process scale up.
4. Experience with authoring IND, CTA, and BLA regulatory documents.
5. Understanding of the application of GMP in the development and production process.
6. Capable of writing details reports and summaries and exhibit detail oriented documentation skills;
7. Communicate effectively and work professionally in a team environment;
8. Highly skilled in Word, Excel, and PowerPoint; experience with statistical DOE software;
9. Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving complicated issues.