Austin P. McDonald

With 26+ years in the pharmaceutical industry, Austin has extensive operations management, regulatory and process engineering experience in the EU, USA and Asia. Austin specializes in facility implementation, product development, product commercialization, strategic planning, regulatory and quality systems and is a recognized subject matter expert in barrier isolator systems, steam sterilization, sterile component handling, sterile filling of vials and syringes, lyophilizers and loading systems, automated inspection systems and the handling of complex materials including, cytotoxic substances, carcinogenic substances, biological hazards and radioactive pharmaceuticals. In addition to speaking at conferences on aseptic processing and barrier isolation technology, Austin is an Adjunct Professor at Stevens Institute of Technology, NJ, where he lectures on GAMP (Good Automated Manufacturing Practices) documentation, project management and the design and implementation of aseptic processes.