Dazhan Liu
Director @Gilead Sciences
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WORK HISTORY
Director @Gilead Sciences
Edmonton, AB, CA
Manufacturing process SME for small molecule DS commercial manufacturing at both internal and external sites-Process chemistry lead for tech transfer and process validation-Establish, maintain and optimize the workflow and system for DS CPV-Regulatory inspection readiness-Continuous process & operation improvements-Root cause analysis and data analysis for commercial investigations & observations Process chemistry SME with a focus on late stage clinical programs-Regulatory filing readiness-Commercial manufacturing readiness and robustness -Design of Experiment, design spaceA member of the department LT
EDUCATION
Fudan University
B.Sc., Polymer Science and Engineering
Texas Tech University
M.Sc., Chemistry
University of Alberta
Ph.D., Organic Chemistry
ABOUT DAZHAN LIU
Responsible for small molecule API process development and qualification, with a focus on late stage and commercial projects. Responsible for the continued process verification (CPV) of commercial API projects. Familiar with small molecule process development including route scouting, process optimization, scale up, process validation and technology transfer.Familiar with risk assessment, design of experiment (DOE) and statistical process control (SPC). Familiar with commercial manufacturing support and post approval change management.
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