Raleigh-Durham-Chapel Hill Area
After a 55-year career in the chemical and biopharmaceutical industries, I am focusing on fixing the world’s Achilles heel – very poor risk analysis skills. From staying safe, selecting political candidates, controlling product contamination, to better designing and operating pharmaceutical plants, man’s inability to adequately analyze risks continues to significantly limit everyone’s ability to achieve their goals. Currently working on furthering CMEA (Causal Mechanism & Effect Analysis) along with advancing: • ReRA (Relational Risk Analysis) using System Risk Structures (SRS) • Prospective Causal Risk Modelling (PCRM) • System Lifecycle Development (SLD) • Multi-Purpose Manufacturing Facilities (MPF) • working Quality by Design (wQbD) • Appropriate Manufacturing Practices (AMPs) • Well-structure Design Space (ws-DS)
Continue developing CMEA (Causal Mechanism & Effect Analysis) using Relational Risk Analysis (ReRA), Highly agile biopharm facility designs, and Process Lifecycle methods.
Provide expertise on operational issues related to engineering biopharmaceutical manufacturing enterprises including cell, gene therapy, and ATMP manufacturing processes. Provide expertise and facilitation of risk management exercises.
Member of the Strategic Manufacturing Concept Group (SMCG) responsible for process assessment, operational analysis, and risk management for conceptual design studies in support of biopharmaceutical projects.
Developed and taught courses on biopharmaceutical processes, Process Validation, Quality by Design, ICH Q8 Design Space, and utility systems design, validation, and operation.
Provided expert conceptual design support, including PFD development, time & motion studies, process scheduling, and internal workflow layouts, for advance products requiring novel process implementations for clinical and commercial manufacturing. Support process transfer, cost of goods (COGs) estimates, and product and process definition for detailed engineering activities. Recent conceptual design and detailed design support projects: • Allogeneic cell therapy using batch re-feed flat plate bioreactors, • Gene therapy product using HeLa cell process for viral vector expansion, • Allogeneic cell therapy using automated perfusion flat plate bioreactors, • Autologous cell therapy facility development using centralized automated systems, • Antibody Drug Conjugate (ADC) facility and process flow development, • Radiological pharmaceutical manufacturing process flow and facility development, • Multi-product, multi-customer MAb contract manufacturing facility.