Edgar Leon
MSAT Director, Validation – Oral Solid Dosage, Drug Product Division
- Role
- Msat Director, Validation Oral Solid Dosage, Drug Product Division at ThermoFisher Scientific
- Location
- Greensboro, NC, US
- LinkedIn followers
- 500 followers
About Edgar Leon
Licensed professional engineer (PE) specializing in pharmaceutical technology transfers, project management, process validation/optimization, relationship business management, pharmaceutical oral solid dosage manufacturing, continuous manufacturing, softgel manufacturing, and powder filling operations.
Experience
Msat Director, Validation Oral Solid Dosage, Drug Product Division
Jan 2026 — Present · High Point, NC, US
Provide global MSAT leadership for lifecycle validation across Oral Solid Dosage drug products, leading the development of global validation standards, procedures, templates, and master plans. Own and govern the Continued Process Verification (CPV) strategy and monitoring programs as CPV Business Process Owner for the Pharma Services Group (PSG), ensuring robust control of critical process parameters and quality attributes. Support manufacturing sites through regulatory inspections, oversee qualification of new and emerging technologies in partnership with Manufacturing and Engineering, and continuously monitor GMP, EU, and FDA regulatory expectations to ensure compliance. Partner closely with Engineering and IT to define validation processes, provide technical expertise, and drive improvements in process efficiency, robustness, and product quality, acting as a Network SME to define and implement technical standards across the MSAT organization.
Education
University of Puerto Rico-Mayaguez
BSIE, Industrial Engineering
1995 — 2000
Polytechnic University of Puerto Rico
MEM, Master's Engineering Management
2002 — 2004
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