Nigel J Smart


SMART Pharmaceutical Consulting




Nigel J Smart, Ph.D. is the President of SMART Pharmaceutical Consulting, a West Chester, Pennsylvania, USA Life Sciences consulting firm. He is a serial entrepreneur with over 35 years in the biotechnology/pharmaceutical industry;30 of those based in North America in both corporate and consulting capacities. He consults on a variety of Life Sciences topics with a particular interest in bioprocess development/manufacturing, in addition to the application of Quality Compliance principles to modern processes. Nigel has acted as an expert consultant for the FDA on cGMP and data Integrity issues, and assists both domestic and foreign companies with Quality Compliance. As part of his government service, Nigel has assisted both BARDA and the Department of Defense in relation to the production of anti-terrorist countermeasures. He has a special interest in the application of LEAN Process Excellence principles to bioprocess manufacturing systems and is the author of a book dedicated to this topic entitled “Lean Biomanufacturing” Oxford Health Publishers.

Area of Interests

Process Technology developments
Manufacturing Technology and Manufacturing Strategy
Quality Compliance
Lean Operations.