27 years' experience in biopharmaceutical industries, specialized on fermentation, cell culture process, cell culture media development, and bioreactor design
Led the National Key Research projects of China and World Bank-sponsored projects (assigned to the Chinese Academy of Sciences)
Developed a high-titer fed-batch cell culture platform with antibody titers up to 15 g/L and won the President's Award at AstraZeneca
Developed a biosimilar cell culture platform for the first biosimilar marketed in China with Henlius
Developed a high-yield cell culture platform which resulted in the first innovative anti-PD-1 antibody marketed in China for TopAlliance
Founded and co-founded several biotech and biopharmaceutical start-ups
Founded Zencore Biologics in 2017
Worked at MIT, Harvard University, University of Pittsburgh, Xencor, AstraZeneca, and Henlius
B.S. of Bioengineering at Tsinghua University, M.S. of Bioengineering at Chinese Academy of Sciences, M.S. of Computer Science at Northeastern University
Nearly 30 years of dedicated experience in the biopharmaceutical industry.
Previously served in senior management positions at internationally renowned pharmaceutical companies such as BI, AZ, LONZA, and Innoforce. Holds multiple technical patents.
Led the process development and commercial manufacturing of multiple key biopharmaceutical products, demonstrating outstanding leadership in registration applications, project management, supply chain management, and market expansion.
Led the development of the first commercial continuous flow upstream and downstream integrated system, iSKID, and chaired key communications with the FDA regarding the regulatory pathways for novel reactors, multi-component PAT (Process Analytical Technology), and continuous downstream processing equipment.
Bachelor's and Master's degrees in Chemistry from Fudan University, Ph.D. in Chemistry from Nankai University, postdoctoral fellow at the Max Planck Institute and the University of California, Santa Cruz, published more than 20 articles in peer-reviewed journals, and has delivered multiple presentations at international biopharmaceutical conferences.
Over 30 years profound experience in the international pharmaceutical industry. Educational background and career journey span North America and Asia.
Held progressive leadership roles at Apotex, Pfizer, Abbvie, Omeros, Adello Bio. Advanced from a bench scientist, Associate Director, Sr. Director to VP roles. Chief Operating Officer (COO) at MabPlex and Frontier Biotech.
Extensive knowledge and experience in the full lifecycle management of antibodies, ADCs, peptides,and small molecules. Possesses end-to-end in-depth understanding in CMC strategies, global regulatory submissions, quality system establishment, CDMO technology transfer, and commercial operations.
B.Sc and M.Sc in Biology at Sun Yat-sen University, and Ph.D in Plant Biochemistry at the University of Western Ontario in Canada.Rewarded with the well-known NSERC/Industry Post-doctoral Fellowship and completed two years's post-doctoral research at Labatts Breweries R&D Institute.
23 years of industrial experience in drug discovery, analytical development, CMC, and regulatory affairs for mAb/BsAb, ADC, CAR-T, and mRNA therapeutics
Senior Scientist and Group Leader at Biogen and MedImmune/AstraZeneca; VP and Sr. VP at Zhejiang Teruisi, Guangzhou Bio-Thera, and Suzhou Abogen; CSO at Changchun Gensciences; CEO at Guangzhou Bio-Gene
Extensive experience supporting dozens of IND and BLA/NDA regulatory filings in China and the United States
Adjunct professor of Jilin University and member of the editorial board of Chinese Journal of Mass Spectrometry
Author of 30 journal publications and 14 patents
B.S. of Physics at Jilin University, Ph.D. of Chemistry at University of Kent at Canterbury, and post-doctorate research at Osaka University and New York University School of Medicine
Effective leader with 30+ years of broad experience in a cGMP / GxP environment of pharmaceutical and biopharmaceutical/ biotechnology industries.
Highly accomplished executive with proven visionary leadership
resulting in teams elevating to high performance organizations and achieving business needs with measurable performance.
Offering experience serving as a kick starter and to refine companies by developing executable strategies and addressing unmet business needs, while aptly achieving cost-effective continuous improvement, and yet attain compliant robust quality systems.
Able to leverage science-based judgment and risk-based application of regulations and guidelines.
A multicultural and matrix leader effective in project management
focusing on successful drug product marketing applications, approval and life cycle management.
30+ years of experience in R&D and manufacturing for biopharmaceutical industry
Worked at Protein Sciences, Human Genome Sciences, Eli Lilly, Progenics, RemeGen, Henlius, and Zelgen
Led the development of over 50 monoclonal and polyclonal antibody drugs
Supported the launch of 11 products in China, Europe, and USA
Achieved technical breakthroughs in large-scale production of monoclonal antibodies and recombinant proteins using mammalian cells in terms of titer, scale, and quality.
Familiar with cGMP standards in Europe and the US, with extensive management experience in large-scale antibody and recombinant protein production; proficient in the entire process of cGMP production facility design, construction, validation, and operation, including expertise in designing large-scale cell culture facilities; led the design and construction of cGMP a variety of production facilities (with 200 liters to 20,000 liters in scale, single-use or stainless steel bio-reactors) .
Published over 50 papers and scientific reports
Selected into the National Talent Program, the Innovation of Shanghai Program, and the Entrepreneurship and Innovation of Jiangsu Program
Served as a member of the Global Expert Group on ICH Q13 Continuous Manufacturing Technical Guidelines, a contributor of technical guidelines for the China National Medical Products Administration (NMPA), a member of the Drug Development Committee of China Pharmaceutical Promotion Association
B.S.& M.S. of Chemical Engineering at China University of Petroleum, MBA of University of Phoenix, Ph.D. of Biotechnology at University of Calgary
10 years' experience in corporate strategy and operation management, including corporate strategy, effective sales management and consulting management
Founded an independent e-sports service brand and serve as CEO
Responsible for the company's strategic planning and construction of organizational operation management system in Zencore
Worked at Nestle Health Sciences and IQVIA
B.S. of Mathematics and Applied Mathematics at Fudan University
18 years' experience in biological quality analysis and project management
Practical experiences in building an analytical laboratory and setting up biopharmaceutical quality analysis team, with the ability to establish a lean operation management process and document system for the analytical department and excellent biopharmaceutical quality analysis ability
Extensive experience in building a project management team and establishing a project management system, including project planning, milestone management, project risk analysis and control strategy, project delivery management, project quality management, etc.
Head of Project Management and Head of Analytical Sciences Department during the tenure at WuXi Biologics (Suzhou site)
B.S. of Science Degree at Jiamusi University, M.S. of Science Degree at Zhejiang Normal University, M.S. of Science Degree at Institute of Botany, the Chinese Academy of Sciences
17+ years' of experience in biopharmaceutical industry
Extensive working experience ranging from antigen and antibody preparation, drug screening to CMC related pharmaceutical research and IND filing, with project experience spanning monoclonal antibodies, bispecific antibodies, combination antibodies, and ADCs
Worked at Shanghai Cancer Research Institute, Shanghai Cellgene, The Central Research Institute of Shanghai Pharmaceuticals Holding Co., Ltd., and Hansoh Pharmaceuticals
Led or involved in the construction of laboratories, production workshops, teams, and document systems from scratch on multiple occasions
Served as project leaders for multiple projects and successfully pushed them from the exploratory phase to IND approval
Authored more than 20 patent applications
B.S. of Chemical Engineering and Technology at Shanghai Normal University, M.S. of Bioengineering at East China University of Science and Technology
10+ years' experience in biomedical R&D and project management
Responsible for building a medium formula development platform and a cell culture process characterization platform
Engaged in cell culture process development, process characterization and culture medium formulation development in Shanghai Destiny Biotech
Developed a highly expressed, animal free and chemically-limited medium formula system for CHO cell culture, and led the team to complete a project based on commercial production scale (500L) in Zencore
Worked at Shanghai Institute of Pharmaceutical Industry, and Shanghai Destiny Biotech
B.S. of Bioengineering at Shenyang Pharmaceutical University, M.S.,Ph.D. of Microbiology and Biochemical Pharmacy at Shanghai Institute of Pharmaceutical Industry
15 years of IT experience, the main achievements including the building of agile product team, e-commerce, digital construction, as well as IT strategic planning and management
Gile development advocate and global architect for the Chinese team, serving as a leader of multiple teams during Dow Chemical
Head of IT Department, responsible for taking over and transferring the e-commerce development team of the US branch, ERP team and all IT solutions for the business counterparts of the domestic company during WuXi AppTec
Senior director of IT Department, build a new IT team for application and solution in one and a half years from scratch during WuXi Diagnostics
Director of IT Department, build a new IT department, and promoted major projects such as e-DOC system implementation, OA upgrade to E9, BI platform construction, GCP system construction and CTMS system selection within a short period of time during Genor Biopharma
Worked at Dow Chemical, WuXi AppTec, WuXi Diagnostics, and Genor Biopharma
B.S. of Information Management and Information System at Tongji University, M.S. of Management Information System at Tongji University