20+ years' experience in R&D and team management in the field of biotechnology and biomedical industry 

Scientist and head of technology management in Medarex, Amersham Pharmacia Biotech, Hologic and ABI/Life Technologies in the United States 

Led the development of a variety of marketed biopharmaceutical products 

Selected into the Overseas High-level Talent Introduction Plan of Shanghai 

Worked at Medarex, Amersham Pharmacia Biotech, Hologic, and ABI / Life Technologies 

B.S. of Anhui Normal University, M.S. of Biophysics at the University of Chinese Academy of Sciences, Ph.D. of Chemical Biology at New York University

20+ years' experience in analytical development and CMC for mAb, ADC, CAR-T, and mRNA therapeutics

Senior scientist and group leader at Biogen and MedImmune/AstraZeneca, VP and Sr VP at Zhejiang Teruisi, Changchun Gensciences, and Suzhou Abogen, CEO at Guangzhou Bio-Gene

Experience of supporting dozens of IND, BLA/NDA regulatory filings in China and United States

Adjunct professor of Jilin University and member of the editorial board of Chinese Journal of Mass Spectrometry

30 journal publications and 7 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

30+ years’ experience in biopharmaceutical industry

Extensive experience in biopharmaceutical CMC, including process development, technology transfer, NDA/BLA filings, and commercial operations

Worked at Shanghai Institute of Biological Products, Indiana University, BioReliance, Amgen, BMS, MedImmune (AstraZeneca), Catalent, Sotio, and Innovent Bio；responsible for dozens of manufacturing projects

At Amgen, commissioned new facility and managed the MSAT team, successfully completed the engineering and PPQ runs , and passed the pre-approval inspections by FDA and EMA 

At BMS, managed the biopharmaceutics manufacturing and completed large-scale mAb product production with an annual throughput of 80 batches 

At AstraZeneca, responsible for the MSAT team, successfully transitioned biophar-maceutical production with annual sales exceeded $1 billion to new plants, completed PPQ runs and passed the FDA pre-approval inspections 

At Innovent Bio, served as the Head of Manufacturing, achieved the market approvals on PD-1 and biosimilar products (e.g., Avastin, Humira, and Rituxan) 

B.S. of Bioengineering at East China University of Science and Technology, M.S. of Biochemistry at Shanghai Institute of Biological Products, MBA of Kelley School of Business, Indiana University

25 years of experience in academia and regulatory affairs directly related to the R&D and manufacturing of biopharmaceuticals. Familiar with FDA regulations

Worked at Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER), National Cancer Institute/Clinical Center Research (NCI/CCR), US R&D Branch/ISU Abxis Korea, and National Heart Lung and Blood Institute (NHLBI)

13 years of Product Quality (aka CMC) reviewer, reviewing Biologics License Applications (BLAs) and Investigational New Drugs (INDs) for biotechnology products under 351(a) and 351(k) BLA pathways during FDA

Participated in the BLA approval process under PDUFA and BSUFA timelines, resulting in the approval of five BLAs and one Complete Response (CR). Reviewed over 40 Supplement BLAs (PAS, CBE30, and CBE), specializing in assay method validation and manufacturing process validation for cell line changes, process scale-up, process changes, and analytical method changes

Expert in FDA compliance regulations for developing biotech products, including monoclonal antibody (mAb), antibody-drug conjugate (ADC), recombinant protein, and biosimilar products

16 journal publications and 1 US patent

M.S. and Ph.D. of Pharmacology at Seoul National University

Over twenty years of experience in the pharmaceutical industry, specializing in QC, QA, and quality system/team build up for greenfield/brownfield projects. Familiar with GXP regulations and testing.

Extensive experience in team building and system support, adept at coordinating and organizing teams to achieve project and quality objectives.

Worked at VISEN, Changchun GeneScience Pharmaceutical (Changchun GenSci), BeiGene, Medtronic, Shanghai Baxter, Advanced Medical Optics (AMO), Wyeth, and USP China.

At VISEN, served as the Quality Head, responsible for supporting the tech transfer of domestic products (from overseas to local production), factory and process preliminary design; factory construction, validation to VMP planning and execution for process PPQ; management of various certificates, system establishment and future internal and external audits; quality management and market support after commercialization.

At Changchun GenSci, served as the Quality Director/Quality Head, responsible for nurturing and enhancing the quality management team while also improving system requirements and practical operation; assisted the company in expanding its business, established the quality systems in three subsidiary companies.

At Bio-Jene, served as the senior quality director, responsible for MAH quality systems and CMO management, post-market management, and license-in Amgen products into the Chinese market.

B.S. of Biochemical Engineering and B.S. of Industrial Enterprise Management at East China University of Science and Technology.

Developed his career as a scientist and an engineer with 20+ years in biotechnology and 12+ years in manufacturing compliance

Extensive experience of working on recombinant proteins, monoclonal antibodies, and vaccines using multiple platforms for expression and purification 

Co-led the Parental Drug Association's effort to document the current industry best practices in Process Validation of Biopharmaceutical Drug Substance Manufacturing 

Fellow of the National Institutes of Health (USA) 

Worked at National Institutes of Health, Bristol Myers Squibb, Sanofi Pasteur, and Samsung Biologics 

Ph.D. of  Wake Forest University, School of Medicine, USA 

10+ years' experience in biomedical R&D and project management 

Worked at Livzon, Lifetech Scientific, Teruisi, GE healthcare life sciences and Shanghai Destiny Biotech

Deeply engaged in cell culture process development and upstream documentation system Responsible for the construction and process development of upstream cell culture departments, taking charge of the overall management of multiple projects in Zencore  

B.S. of Changchun University of Science and Technology, M.S. of Hunan Normal University, 

10 years' of biomedicine experience, involving downstream process development, technology transfer and GMP production 

Completed the downstream process development of 8 recombinant proteins, scaling from 2L process to 200L process 

Transferred 4 monoclonal antibody projects from foreign factories to the Shanghai GMP factory, and led the team members to complete multiple batches of 500L and 2,000L GMP production 

Senior scientist of CS & T Department during Boehringer Ingelheim 

Worked at Boehringer Ingelheim, and Genor Biopharma 

M.S. of 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 

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

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 

15 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 Biological Department of MabSpace Biosciences during Transcenta 

Head of Project Management and Analytical Sciences of CMAB during WuXi Biologics 

Worked at Transcenta and WuXi Biologics 

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

7 years' experience in technology development and market promotion of upstream cell line, culture medium and downstream filtration 

Senior sales application specialist, responsible for cell line business in China market, large investment projects of more than 1 million euros in North, East and South China, and culture medium business during Merk 

Senior account manager, responsible for the technical and marketing work of Chinese biological product enterprises during Asahi-KASEI Bioprocess 

Worked at Merk, Asahi-KASEI Bioprocess, and Sundia 

Ph.D. of East China University of Science and Technology, MBA of BI Norwegian Business School 

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

13 years of finance management experience in large multinational enterprises with the ACCA certificate 

Responsible for the finance management of the Life Sciences Department and the Analytical Instruments Department in Asia, and the global business of the Analytical Instruments Department (about $900m annual sales) during PerkinElmer 

Experience of working for multi business groups (medical, energy, finance, aviation, etc.) with three years of overseas work experience during General Electric Company 

Senior finance manager of Asian region during Energy Group 

Responsible for the financial integration of the Asia region post-merger and acquisition during Alstom

Worked at PerkinElmer, General Electric Company, Energy Group, and Alstom 

M.S.,B.S. of Management and Literature at Shanghai University of Finance and Economics

15 years' experience in end-to-end purchasing management, budget control, supply chain digitization, category management, supplier management 

Holds the CPM (Certified Purchasing Manager) certificate and the SA8000 (Accounting for Social Responsibility) certificate 

Procurement Head of R&D Center during Novartis 

Head of Supply Chain Management and Procurement during Columbia Healthcare 

Director of Material Management during Delta Healthcare 

Director of Procurement during Innovent Bio 

Head of Procurement in the R&D center and Global Procurement Compliance manager during Roche 

Worked at Novartis (China), Roche, Delta Healthcare, Columbia Healthcare, and Innovent Bio 

B.S. of Clinical Medicine at Shanghai University of Chinese Medicine 

20 years' experience in production quality management 

Familiar with the requirements of both China and US quality system and the registration and application requirements of biological drugs 

Responsible for the R&D quality assurance and registration in Zencore 

Worked at GE Healthcare and Henlius 

B.S. of Pharmaceutical Preparations at China Pharmaceutical University