Nigel J. Smart, Ph.D.

Biography

Nigel J. Smart, Ph.D., is the founder and principle of SMART Pharmaceutical Consulting LLC, a progressive and innovative provider of solutions to the Life Sciences industry, including small, medium and large pharma/biotech/device industry companies, the FDA, Federal Trade Commission and the Department of Defense.

He is a serial entrepreneur with over 40 years in the biotechnology/pharmaceutical industry; 36 of those based in North America in both corporate and consulting capacities. He has initiated several startup companies, has numerous patents associated with cultivating cells for medical products and has a commercial bioreactor for cell products marketed by LH Fermentation, a major bioreactor company.

He consults internationally on a variety of Life Sciences topics with particular interest in Bioprocess Development/Manufacturing, and the application of Quality Compliance principles to modern processes. He is someone that is in search of High-Performance outcomes and to that end is open to new approaches that add value. Currently he is reviewing where Ai may be employed together with existing technology to generate improved strategies in audit outcomes and non-conformance improvement.

In 2020 Nigel pioneered the idea of virtual audits and prepared a successful protocol for the application of the same during the Covid-19 pandemic. This has since been applied to hundreds of successful audits internationally.

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 the relation to the production of anti-terrorist countermeasures for which he received a commendation from the Department of Defense for his work in producing the Anthrax vaccine. Nigel has at the core of his skill set his curios enquiring mindset that is always looking for imaginative/creative solution approaches.

He has a special interest in the application of LEAN Process Excellence principles to Bioprocess Manufacturing systems/Quality and has authored papers presented at international conferences, in chapters & books connected with the topic.

Currently he is writing on the topic of Ai and Human Agency as a form of Cooperative intelligence and the future effect on Quality, Productivity and Efficiency for Life Science processes.



Nigel Has a BSs Hons in Chemistry from the University Leicester, UK, an MSc in Fermentation Technology/Natural products from the Victoria University of Manchester, UK and a PhD in Fermentation Technology/Eng for Novel penicillin antibiotics from The Victoria University of Manchester UK. 

Publications

Challenges in the production of High-Quality Pharmaceuticals, CPHi Shanghai 6/2018.

FDA Inspection Readiness; 2-day Workshop to the Indian Pharma Industry, Mumbai/Hyderabad, 10/2019.

Client Audits and the Future of audits post Covid 19, PBOA Annual Meeting, DC 10/2022.

The Impact of Ai on MedTech manufacturing. Seminar, Medtech group of California; April 2025.

The author of a book dedicated to this topic entitled “Lean Biomanufacturing” Oxford Health Publishers 2013.