Lead biosimilar and novel biologics technical and business development. Build in-house technical capabilities, such as glycosylation control during cell culture process development, high density perfusion cell culture with product retention, commercial GMP manufacturing facility design and process scale-up and tech transfer, etc. Seek and evaluate business collaborations and new technologies fit for corporate strategic goals of biologics development. Oversee the biologics development program across different stages and different functional areas of biology research, cell line development, process development (cell culture, purification, analytical and formulation), scale-up, commercial manufacturing and tech transfer processes.

Develop state-of-the-art next generation biosimilar platform for antibody/fusion protein products. Lead streamline high-throughput development activities. Manage CMO scale-up and GMP purification manufacturing activities (400L, 1600L and 20,000L). Build and deepen the in-house purification development capability. Establish best-in-class industry practice in defining best path forward to bringing biosimilar products to the highly-regulated US and EU markets.

Led glycoprotein rpFVIII phase 3 purification process development (1250 L total harvest per batch), optimization and process validation activities by implementing QbD and utilizing advanced statistical tools. Authored and managed BLA submission supporting documents. Supported manufacturing operation and deviation investigations on a routine basis. Developed in-process and DS analytical methods to support new process development. Improved process purity by reduction of host cell proteins meanwhile enhancing process yield within the challenging timeline. Extensive experience in setting up a process development team and pilot plant to support commercial scale production. Continuously seek and adapt “best in class” and “first in class” practices within the industry. Extensive experience of coordinating different group activities, including process development, analytical development, manufacturing and QC, QA to achieve corporate goals. Extensive experience in tech transfer in-house and to the 3rd party CMOs and CROs. First site certified Green Belt Champion of Operational Excellence.

Supported commercial product Cubicin manufacturing activities at oversea CMO site leading to FDA PAI approval. Actively participated in US FDA PAI activities on site.Led process development efforts in filing IND. Set up in-house process development lab and pilot plant to support API commercial production. Established in-house process development expertise and talent. Responsible for in-house pre-clinical production, process development, vendor selection and novel process technology evaluation. Trained and supervised junior scientists both within and outside manufacturing department.

Developed clinical and commerical stage purification process of several recomibnant protein/peptide products and moncolonal antibody products. Started a scale-up lab to support pre-clincal material supply to CMC team as well as initial assesment of scale-up before the program moves to clinical supply. Participated in several tech transfer and outsourcing processes. Worked under cGMP conditions to make clinical trial materials in the pilot plant.

Responsible for Northern China's territory commercial launch, promotion and sales of its Dipravan product

Responsible for sales and promotion in Northen China terriotory with more than 30 hosptials' accounts

Resposible for commerical development of many enzymes used in industries. Specialized in purification technologies.