Sean Guo

Principal Consultant Owner @Pa Pharma Cmc Consulting, Llc

Boston, MA, US

Technical consulting firm focusing on assisting the pharmaceutical/biopharmaceutical industry with their needs in analytical development, QC, stability, CMC regulatory, product development and CDMO supervision ranging from discovery to FIH to commercialization.• Remote and on-site consultation services as well as in-plant and wet-lab support.• Author and review CTD Module 3 CMC sections for IND, IMPD etc.• Manage analytical, QC and other CMC development and GMP activities at CDMOs, enabling compliance with regulatory requirements.• Prepare development plans and perform gap analysis, risk assessment, OOS/OOT troubleshooting as well as root-cause investigations, enabling manufacturing of quality clinical trial drug substances and products.LinkedIn — —

Nanjing University

Bachelor's Degree

Nanjing University

Master's Degree

Brown University

Doctor of Philosophy (Ph.D.)