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

  1. Msat Director, Validation Oral Solid Dosage, Drug Product Division

    ThermoFisher Scientific

    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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Edgar Leon — Msat Director, Validation Oral Solid Dosage, Drug Product Division at ThermoFisher Scientific in Greensboro, NC, US | Unifers