James’ 30 years of professional work includes 15 years' experience in Biotechnology, 2 years in Quality Engineering consulting, and 13 years as a Research and Development Chemist. James served in global roles at the Director level with several leading Biotechnology firms and his responsibilities ranged across several areas including Commercial and Clinical Quality Assurance and Quality Engineering. Key areas include Contract Manufacturing, Quality Assurance, Regulatory Compliance, Process Technology Transfer, Quality Risk Management, Quality by Design, and Six Sigma.