Thomas McMahon

Tom leads SciLucent’s Manufacturing & Development and its Quality & Compliance practice areas. He provides operational, regulatory, and quality support to the healthcare products industry worldwide and has nearly 25 years of drug development experience. Tom’s expertise includes integrated product development; strategic CMC programming; operational oversight of manufacturing and supply chains; vendor contracting and management; leading interactions with regulatory authorities; regulatory submission/report preparation; quality systems development and implementation; CMC quality oversight; GMP compliance auditing and remediation; market and licensing due diligence reviews; and scientific/regulatory issue research and analysis. Tom has aided numerous pharmaceutical and biopharmaceutical clients with various aspects of CMC product development including formulation development, process and method development/validation, stability programming, etc. Tom’s experience includes numerous classes of active pharmaceutical ingredients, dosage forms, manufacturing processes, and analytical methodologies. Tom has developed integrated CMC regulatory strategies for products seeking multi-regional approval (e.g., US, Canada, EU, etc.) and led or participated in meetings focused on CMC content with regulatory authorities. Tom has a B.S. in Biology from the College of William and Mary.