Kevin is a chartered chemical engineer with over 30 years of global experience in the design of biopharmaceutical manufacturing facilities. Based in Dublin, he is part of the company’s Global Strategy and Technology (GS&T) group. He has led over a hundred large molecule biologics, vaccines, and sterile fill-finish projects, from master planning, feasibility studies through detailed design.
He is an expert in drug product facility design and technology evaluation, including biological and high potent containment in a CGMP production environment. Kevin has worked as a drug product subject matter expert (SME) on significant pharmaceutical projects across an ever-evolving regulatory compliance landscape.
Kevin has extensive biopharmaceutical process design experience including P&D development, HAZOP chair, regulatory compliance audits, equipment technology evaluation, and compliance with client local and global standards.
He is an active committee member of the PDA and ISPE Ireland Affiliate Committees and regularly chaired and organised technical seminars in Ireland for both organisations. He possesses excellent technical knowledge and a passion for peer development.
Education
- B.Eng - Chemical Engineering (Biochemical Stream), University College Dublin
Professional Associations
- Institution of Chemical Engineers (IChemE)
- International Society for Pharmaceutical Engineering (ISPE)
- Parenteral Drug Association (PDA)
Publications
- Smyth, Kevin. “Generation Pharma - Graduates Find What They’re Looking for in Thriving Industry.” The Engineers Journal, May /June 2012
- Smyth, Kevin. “A Prescription for Growth - The Pharma Blue Print.” The Engineers Journal, May /June 2012
- Smyth, Kevin. PDA Ireland Chapter, “Minimizing risk in Aseptic Facility Design and Delivery.” UCD, February 2008
Presentations
- Smyth, Kevin. “Disruptive Technologies in an Ever-Evolving Bio Pharma Environment.” ACHEMA Pulse Virtual Conference. 16 June 2021.
- Smyth, Kevin. “BioPharma Cell and Gene Therapy Challenges and Solutions in an Ever-Evolving Regulatory Landscape.” PDA Annual Meeting, March 2021.
- Smyth, Kevin. "Minimizing Risk in Aseptic Facility Design and Delivery," USD, February 2008