1 Sterile Products Expert Witness Found
Results Sorted Below by State
Stuart G Levy SGL Chemistry Consulting, LLC
Arlington, Massachusetts
Pharmaceutical Research, Chemistry & Chemicals
-
API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism
HIGHLIGHTS
• Twenty-eight years of industrial experience in all aspects of chemical development
• Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities
• Eighteen years of experience in devising and executing integrated CMC development programs
• Hands-on, results-oriented leadership of CMC development and multidisciplinary teams
• Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting....