Kenneth Chen
Executive Director of CMC Management at WuXi Biologics
- Role
- Executive Director of Cmc Management at WuXi Biologics
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Kenneth Chen
Biopharmaceutical professional with 20+ years of experience in CMC, Quality, and Regulatory. Extensive experience in development and commercialization of biologics, vaccines, and pharmaceuticals. A visionary leader and analytical thinker with creative problem solving capability. Excellent leadership and communication skills to effectively communicate with global health authorities. Aspire to improve animal and human health through regulatory science and quality leadership.Specialties: Regulatory CMC for IND/CTA and BLA/MAA, implementation of risk based quality systems, analytical and stability strategy, CRO/CMO oversight, stakeholder collaboration, and alliance management.
Experience
Executive Director of Cmc Management
Jan 2023 — Present · US
Education
University at Buffalo
Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences
2002
USC Marshall School of Business
MBA, Operation Management
2009 — 2012
Skills
- Technology Transfer
- R&D
- CRO
- Validation
- Quality Assurance
- Hplc
- Formulation
- Pharmaceutical Industry
- Drug Development
- Biopharmaceuticals
- Biotechnology
- Life Sciences
- Research and Development (R&D)
- Glp
- Financial Analysis
- Strategy
- High-Performance Liquid Chromatography (Hplc)
- Cross-Functional Team Leadership
- Gmp
- Regulatory Affairs
- Lifesciences
- Purification
- Quality System
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