Dr. STU IRWIN

Operational excellence leader and bioprocess manufacturing expert with over two decades of experience driving transformational change in highly regulated life science environments. A proven architect of manufacturing efficiency, quality integration, and risk mitigation strategies, I specialize in installing Lean Six Sigma systems, cross-functional governance models, and real-time process monitoring in settings ranging from clinical-stage CDMOs to commercial-scale biomanufacturers.

My career spans critical roles in biopharmaceutical manufacturing, quality assurance, regulatory affairs, and technical project management—delivering results across cell and gene therapy, biologics, and advanced tissue engineering. I have successfully led facility start-ups, process standardization, technology transfers, and GMP remediation projects in complex, compliance-sensitive environments. As both a former executive and an independent consultant, I have supported first-in-human trials, IND-enabling studies, cost of goods modeling, and strategic portfolio realignment for high-growth biotech firms.

Holding a Ph.D. in Medicine, an MBA focused on innovation management, and Black Belt certification in Lean Six Sigma, I bring scientific rigor, operational discipline, and strategic foresight to every engagement. My leadership philosophy is grounded in data transparency, team development, and continuous improvement—a foundation that empowers bioprocess organizations to scale efficiently, meet regulatory expectations, and accelerate time-to-clinic.

- Head of Manufacturing for preclinical through pivotal trials resulting in a $1B valuation

- Installed and operated quality management systems

- Led GAP analysis and refurbishment of four facilities to meet GMP requirements

- Rapid stabilization and reorganization of CDMO Engineering/Facilities

- Led SME teams / 22 international technical projects major strategic shifts

In the spring of 2018 I relocated to NZ. During this time I also started a small consultancy called Bioprocess Consultants NZ. After completing my research at the University of Auckland, I returned to the USA and began operating under the name RedRock Bioprocess Consulting, based in downtown Denver, Colorado.

https://orcid.org/0000-0002-0379-573X

https://orcid.org/0000-0002-0379-573X

Lean Six Sigma Black Belt

• Consultant, National Science Foundation
• Advisor, Innosphere Ventures
• Advisor and Grant Reviewer, Advanced Industries, Colorado Office of Economic Development and International Trade
• Council Member, Gerson Lehrman Group