Xuejun Gu
Chief Technology Officer @ WuXi Biologics
About
20 years of Biotech experience with both strong technical and leadership capability, augmented by broad project management experience. Highly motivated and strong ability for execution. Specialties: • Bioprocess API Development & BioManufacturing Operations • Project Management at both program team and CMC component • Strategic Planning & Effective Execution • Team Building & Talents Development • Critical Chain Timeline Management and Six sigma • Fluent in Chinese (Mandarin] and English
United States
Zionsville
Biotechnology
Biotechnology, Technology Transfer, Life Sciences, Biopharmaceuticals, Pharmaceutical Industry, GMP, Drug Discovery, Drug Development, Cell Culture, Protein Chemistry
Experience

SVP of CMC Management and Project Development
WuXi Biologics

Head of Purification and Virology
Indianapolis, Indiana Area
Led the functional area of downstream development with a staff member of 40 scientists including 10 senior scientists for purification and virology development to support early and late stage development in terms of technical advancement and project deliverables to meet business needs; responsibilities including technical oversight, business planning and integration, budget & capacity planning, outsourcing, recruiting, leadership development and talent succession.

Advisor
CMC Project Management
Completely responsible for CMC strategy & deliverables, budget, timeline and product team integration in support of clinical supply, regulatory BLA submission and commercialization.

Head-Molecular Biology, Cell Culture and Fermentation
Indianapolis, Indiana Area
Led the functional area of upstream development with a staff member of 50 scientists including 10 Ph. Ds for cell line development, cell culture and scale up operation to support early and late stage development in terms of technical advancement and project deliverables to meet business needs; responsibilities including technical oversight, business planning and integration, budget & capacity planning, outsourcing, recruiting, leadership development and talent succession.

Principal Scientist
Developed the platform of cell culture process and medium package & fed-batch cell culture processes as the mammalian cell culture capability, this platform has supported all Lilly’s bioproduct process development from mammalian cell culture to support development from pre-clinical to Phase 3; supervised a staff from 3-9 members including Ph. Ds.
Xuejun Gu's Contact Information
Phone
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