Personal Information
Organization / Workplace
Greater Philadelphia Area United States
Occupation
Independent Biotech Consultant
Industry
Medical / Health Care / Pharmaceuticals
About
Technical Operations and CMC Executive with 25 years of vaccines and biotech experience (drug substance and drug product) in Technical Operations and three years experience in Market Development /Advocate Development. Experience includes management of operations regulated by the FDA, EMA, Canadian and other regulatory agencies; technical and managmement/systems supporting clinical and commercial development and manufacturing. Strengths in process validation activities, license submissions, process change control management, optimization of product yields by process improvements, drug substance and drug product characterizations, cell banks manufacturing and characterizations, chemical a...
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