Don Nguyen ChE, MBA, Master Black Belt MBB

Results-driven and innovative pharmaceutical leader with 28+ years of experience, including 10 years in Associate Director and Director roles overseeing technical services, internal/external manufacturing, and global manufacturing networks. Extensive technical expertise across oral solid dose, sterile, liquid, creams, inhalation, nasal spray, injectables, oral thin films, combination products, devices, and API manufacturing. Proven track record in designing and executing strategies for process development, technology transfer, process validation, engineering, scale-up, optimization, and robustness, while maintaining compliance with FDA, EMA, ISO, and global regulatory requirements. Certified Lean Six Sigma Master Black Belt and recognized Subject Matter Expert in problem-solving, statistical analysis, DOE, QbD, CPV, and continuous improvement. Skilled in integrating artificial intelligence and advanced analytics into CPV monitoring, Six Sigma projects, root cause analysis, and investigations, leveraging predictive modeling, anomaly detection, and machine learning to accelerate insights, enhance process robustness, and reduce investigation cycle times. Proven leadership in managing technical support and product/process robustness initiatives for internal sites and external manufacturing partners (CMO/CDMO) worldwide, delivering measurable gains in quality, efficiency, and cost-effectiveness. Experienced trainer and coach, having delivered technical and process robustness programs to 40+ global sites across the Americas, Europe, Asia, and Latin America, as well as FDA agency personnel. Familiar with Industry 4.0 and Smart Factory concepts.