Thomas L. McMahon (Tom)

Areas of Expertise:

Thomas McMahon

Tom is a Director of SciLucent who leads the Company’s CMC, Compliance and Quality Assurance practice, which provides operational, regulatory, quality, and business support to the healthcare products industry worldwide. He specializes in the management of CMC regulatory and operational development programs, manufacturing compliance, and quality assurance. His experience includes pharmaceuticals, biologics, dietary supplements, medical gases, and cosmetics. Tom has managed projects across all stages of development, from medicinal chemistry to IND-enablement and through clinical supply onwards to commercial launch. Additionally Tom has overseen teams responsible for commercial supply chains and post-approval change implementation. He has developed integrated CMC regulatory strategies for products in both the FDA and the European Medicines Agency. He has written and managed the compilation of DMFs and CMC/Quality sections of INDs, IMPDs, NDAs, MAAs, NDSs, submission amendments and supplements, as well as the filing of United States Pharmacopeia monograph applications. Tom has significant experience in cGMP auditing and has managed teams that organized and implemented cGMP/QSR-compliant quality management systems for pharmaceutical, biologic, dietary supplement manufacturers, as well as pharmacy compounding and repackaging operations. Tom has a B.S. in Biology from The College of William and Mary and over 20 years of drug development experience.