Danhua Chen, Ph.D.
About Danhua Chen, Ph.D.
Danhua Chen, Ph.D., is the Senior Director of Chemistry and Technology at Travere Therapeutics, where he has worked since 2014. He has extensive experience in analytical chemistry and has held various leadership roles in the pharmaceutical industry, including positions at Pfizer, Teva Pharmaceuticals, and Alliance Pharmaceuticals.
Work at Travere Therapeutics
Danhua Chen, Ph.D. has served as the Senior Director of Chemistry and Technology at Travere Therapeutics since 2014. In this role, he leads the analytical group and oversees contract manufacturing organization (CMO) activities for active pharmaceutical ingredient (API) manufacturing. His responsibilities include ensuring the validation of processes and methods at external laboratories, which is crucial for maintaining quality standards in pharmaceutical development.
Previous Experience in Pharmaceutical Industry
Prior to his current role, Danhua Chen held several significant positions in the pharmaceutical industry. He worked at Alliance Pharmaceuticals as Principal Scientist and Head of Analytical Chemistry for one year. He also served as Director of the Department of Analytical Sciences at Teva Pharmaceuticals from 2009 to 2011 and as Sr. Principal Scientist at Pfizer from 2003 to 2009. His experience spans various aspects of analytical chemistry and project management.
Leadership in Analytical Chemistry
As the head of the analytical group at Travere Therapeutics, Danhua Chen has a proven track record in resolving analytical issues through strategic and systematic approaches. He has conducted comprehensive Chemistry, Manufacturing, and Controls (CMC) assessments, including technical risk mitigation for API and drug product (DP) manufacturing. His leadership ensures that clear recommendations are provided to upper management and the business development team.
Education and Expertise
Danhua Chen earned his Doctor of Philosophy (Ph.D.) in Analytical Chemistry from Wuhan University. He also holds a Doctor of Philosophy (Ph.D.) in Biotechnology from the University of Wisconsin-Madison. His educational background provides a strong foundation for his expertise in analytical chemistry and pharmaceutical development.
Key Projects and Contributions
During his career, Danhua Chen has managed significant projects, including the Sparsentan project in collaboration with Wuxi/STA, where he ensured the successful supply and on-time delivery of API. He also conducted structure analysis for Cholbam impurity identification, confirming the impurity as Linoleic acid through experiments at a contract research organization (CRO) using liquid chromatography-mass spectrometry (LC/MS).