Junhua Chen

Background

About Junhua Chen

I am an Organic Chemist and CMC Scientist with over a decade of combined academic and industrial experience advancing small molecule drug substances from route design through IND-enabling development and GMP manufacturing.My work focuses on process chemistry, regulatory compliance, and technology transfer for clinical readiness. I have successfully delivered multiple GLP and cGMP batches supporting preclinical toxicology studies and first-in-human trials. My expertise spans early process development/route scouting, impurity control, polymorph management, and solid-state characterization, with hands-on experience authoring GMP batch records, deviation reports, and campaign summaries in alignment with ICH/FDA guidelines.I also bring a strong academic foundation, which allows me to effectively bridge chemistry and CMC strategy—partnering with Analytical, Solid-State, Formulation, and Quality teams to ensure robust, phase-appropriate processes.