Thomas McMahon

Tom leads SciLucent’s CMC & Quality practice area, which provides strategic and operational support to clients in manufacturing, controls, compliance, and sponsor quality management involved in the development and commercialization of products.   He has 30 years of drug development experience with expertise relating to integrated product development; strategic CMC programming; operational oversight of manufacturing and controls; vendor contracting and supply chain management; leading interactions with regulatory authorities; regulatory submission/report preparation; quality systems development and implementation; quality oversight of CMC activities; GMP compliance auditing and remediation; market and licensing due diligence reviews; and scientific/regulatory issue research and analysis.  Tom provides guidance and support to clients on various aspects of CMC product development including process, formulation, and analytical controls development, comparability assessments, stability programming, control strategies, and stage-of-development data requirements and quality expectations.  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.