Weichang Zhou

Overseeing the company's technical operations organization, leading CMC strategy and all aspects of preclinical, clinical, commercial biopharmaceutical sciences, and manufacturing and quality operations.

Honorary President of Global Biologics Development and Operations and Senior Advisor to Chief Executive Officer in a part-time capacity to further support WuXi Biologics’ long-term development by leveraging my expertise and insights to contribute to the company's long-term growth and success. Non-Executive Director of WuXi Biologics and WuXi XDC.

Served as an Executive Director of the Board, Chief Technology Officer, and President of Global Biologics Development and Operations, and led not only global biologics development and manufacturing functions including a team of more than 5000 scientists and engineers with diversified backgrounds providing integrated biologics development and CMC services to support numerous programs including development of cell lines, cell culture, purification, bioconjugation processes, analytical methods, formulation and fill and finish, biosafety testing, cell banking as well as manufacturing and release of pilot-scale tox supplies and early stage clinical supplies in addition to developing new technology and capability platforms including microbial fermentation and viral production platforms, but also global operational functions such as Global Information and Technology (GIT), Global Automation Integrated Service (GAIS), and Environment, Health, and Safety (EHS) with a total staff of more than 200. Also served as a director of WuXi XDC Cayman Inc., providing guidance on corporate strategy and governance.

Led a team of more than 2500 scientists and engineers with diversified backgrounds providing integrated biologics development and CMC services to support numerous programs including development of cell lines, cell culture, purification, bioconjugation processes, analytical methods, formulation and fill and finish, biosafety testing, cell banking as well as manufacturing and release of pilot-scale tox supplies and early stage clinical supplies in addition to developing new technology and capability platforms including microbial fermentation and viral production platforms.

Chief Technology officer Since November 2016 Led a team of more than 1,000 scientists and engineers with diversified backgrounds providing integrated biologics development and CMC services to support numerous programs including development of cell lines, cell culture, purification, bioconjugation processes, analytical methods, formulation and fill and finish, biosafety testing, cell banking as well as manufacturing and release of pilot-scale tox supplies and early stage clinical supplies.

Responsible for all biologics development and CMC activities, manufacturing of early stage clinical supplies. Led a team of more than 500 scientists and engineers with diversified backgrounds providing integrated services to support many biologics development and manufacturing programs including development of cell lines, drug substance processes, analytical methods, formulation and fill and finish, as well as manufacturing and release of pilot-scale tox supplies and early stage clinical supplies.

Responsible for all biologics process development and CMC activities including development of cell lines, cell culture, purification and antibody drug conjugation processes, analytical methods, formulation and fill and finish, as well as technology transfer for manufacturing of monoclonal antibodies, fusion proteins, antibody drug conjugates and recombinant proteins; Led a team of more than 400 scientists and engineers with diversified backgrounds providing integrated services to support a number of biologics development and manufacturing programs.

Led development, scale-up, characterization, transfer of perfusion and fed-batch mammalian cell culture processes for commercial manufacturing of biologics, led development of viral risk mitigation technology platforms, provided cell culture expertise to support validation and continuous improvement of large-scale microcarrier-based perfusion manufacturing processes, and regulatory filings and interactions with agencies including FDA and EMA for several commercial biologics products.

Responsible for development, scale-up, transfer, validation of manufacturing processes, and support for clinical and commercial production of monoclonal antibodies, having enabled successful regulatory filings for 7 antibody candidates, and successful manufacturing of these antibody candidates at up to 16,000 L scale.

Provided oversight of development of a large-scale PER.C6TM cell growth, Adenovirus propagation and recovery process for manufacturing of a trivalent HIV-1 vaccine candidate; co-led the company’s Biologics Pilot Plant start-up, and the scale-up of the Adenovirus culture, recovery and purification processes for clinical manufacturing at 1,000 and 2,000 L scale; led development of Merck’s licensed manufacturing process for the pentavalent bovine-human reassortant live, oral Rotavirus vaccine, RotaTeq® (approved by FDA on Feb 3, 2006) from cell culture to sterile bulk, Master and Stock Virus Seeds, and technology transfer for the commercial manufacturing facility development.