David Gao
Vice President of Technical Operations
- Role
- VP, Technical Operations at Maze Therapeutics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About David Gao
Pharmaceutical development professional with over 20 years of extensive experience in CMC (Chemistry, Manufacturing and Controls), and technology transfer; Excellent organizational skills and leadership demonstrated in strategic planning, execution and performance management; Strong ability to solve problems of diverse scope.Specialties: •Pharmaceutical development and quality systems •Knowledge of GMP and GLP requirements and ICH guidelines •Technical writing of regulatory documents for CMC (IND, e-CTD, NDA, MAA) •Outsourcing and tech transfer to CROs and CMOs and monitoring their activities
Experience
VP, Technical Operations
Aug 2023 — Present · South San Francisco, CA, US
Responsible for the drug substance and drug product process development and manufaturing, analytical development and testing, and CMC strategy and execution.
Education
Iowa State University
PhD, Analytical Chemistry
1995 — 1999
Peking University
MS & BS, Organic Chemistry
San José State University
MBA, General Management
2000 — 2003
Skills
- Nda
- Instrumentation
- Validation
- Pharmaceutical Management
- Method Development
- Technical Transfers
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