Group Vice President, Head of Biopharma @ Qilu Pharmaceuticals
SVP and Head, Bioprocess Development & Manufacturing @ BeiGene
Vice President & Site Head, Biomanufacturing @ WuXi AppTec
Sichuan Industrial Institute of Antibiotics
Obtained Ph.D. in Biochemical Engineering from MIT in 1991 under supervision of Professor Arnold Demain. Spent next 15 years in Bioprocess R&D, Merck, lastly as Senior Investigator, then over a year in Novavax as Executive Director, Bioprocess R&D, and 7 years as VP, Process Development & Manufacturing in Immunomedics. Worked in WuXi AppTec in China from Mar
Obtained Ph.D. in Biochemical Engineering from MIT in 1991 under supervision of Professor Arnold Demain. Spent next 15 years in Bioprocess R&D, Merck, lastly as Senior Investigator, then over a year in Novavax as Executive Director, Bioprocess R&D, and 7 years as VP, Process Development & Manufacturing in Immunomedics. Worked in WuXi AppTec in China from Mar 2014 to Aug 2015 as VP and Site Head of Biomanufacturing. Currently serving as SVP and Head of Bioprocess Development & Manufacturing in BeiGene.
Comprehensive knowledge and managerial experiences in directing bioprocess development (both up- and down-stream) and clinical manufacturing, with responsibility for a commercial manufacturing as well. Extensive experiences in partner collaboration, contract manufacturing, due diligence, and technology transfer. Detailed familiarity with all aspects of QC/QA and cGMP compliance. Full awareness of current FDA/EMA regulations on biopharmaceuticals including biosimilars. Key contributor/author for numerous CMC and IMPD filings. Demonstrated high level leadership and effectiveness in project coordination and management, with critical insight and in-depth analytical ability in technical review and communication. Practical knowledge and experience in business strategy development and budget planning. Proven skills in operating under limited resources and timelines.
Strong technical expertise in microbial fermentation and mammalian cell culture process development and clinical manufacturing for biological products, including natural products, vaccines, monoclonal antibodies and ADCs/bispecifics. Extensive experiences and comprehensive knowledge in cell line, medium, cell culture, bioreactor scale-up, purification, formulation, conjugation, fill/finish, bioanalytical characterization, and cGMP manufacturing. Well established expert in medium/upstream development. Forty published papers. Journal editors/reviewers.
SVP and Head, Bioprocess Development & Manufacturing @ Responsible for biomanufacturing facility build-up, bioprocess development, and clinical/commercial manufacturing (in-house and/or through CMOs) for biopharmaceuticals. From September 2015 to Present (4 months) Vice President & Site Head, Biomanufacturing @ Lead site activities in biomanufacturing for monoclonal antibodies, therapeutic proteins and enzymes, including tech transfer, raw material management, manufacturing, fill/finish, quality control, and facility engineering, etc. From March 2014 to August 2015 (1 year 6 months) Wuxi, Jiangsu, ChinaVice President, Process Development & Manufacturing @ Led company activities in cell line, cell culture and downstream process development and cGMP manufacturing for naked monoclonal antibodies as well as their bispecifics and drug/radiolabeled conjugates. From June 2007 to February 2014 (6 years 9 months) Executive Director, Bioprocess R&D @ Led bioprocess R&D and clinical manufacturing for virus-like particle vaccines in insect cell culture. From May 2006 to May 2007 (1 year 1 month) Sr. Investigator @ Led groups in BPR&D to research and develop processes for natural product therapeutics, recombinant proteins, vaccines and monoclonal antiobodies using microbial fermentation and mammalian cell culture. From August 1991 to April 2006 (14 years 9 months)
Ph.D., Biochemical Engineering @ Massachusetts Institute of Technology From 1987 to 1991 M.S., Microbial Pharmaceutics @ Sichuan Industrial Institute of Antibiotics From 1982 to 1985 B.S., Biochemical Engineering @ East China University of Science and Technology From 1978 to 1982 Jinyou Zhang is skilled in: Biopharmaceuticals, GMP, Technology Transfer, Vaccines, Cell Culture, Fermentation, Purification, Biotechnology, Monoclonal Antibodies, Pharmaceutical Industry, Cell, R&D, FDA, Drug Discovery, Formulation
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