Biologics CMC development and manufacturing, from stable cell line development, cell banking, process development, formulation, aseptic filling and freeze-drying, to IND and NDA application.

1) Responsible for R&D of biological drug products. 2) In charge of the development of antibody-drug conjugates (ADC) and established ADC research and production platform in CP Guojian.3) Collaborate with external partners/comapnies to license in/out new drug product pipelines and technologies.

Various positions at Bayer Healthcare, Pharmaceuticals in Berkeley, California since Dec. 2000. Specialties include the following: 1) Expertise in the areas of CMC, from small scale to production scale. 2) Drug product development from preclinical to clinical phase III.3) 10 plus years of experiences in managing various projects.4) Many experiences in Registration Documents preparation for regulatory submission, such as IND/IMPD, NDA/BLA filing, etc.