Bio

Experienced global Biopharmaceutical Cell/Gene Therapy operations executive, offering more than 41 years of demonstrated management and senior leadership in Manufacturing, Quality and Technical Operations for the clinical/commercial pharmaceutical industry. Extensive experience in Quality US FDA and ROW compliance inspection management and regulatory interactions. Skilled in directing full tech transfer of complex, large and small scale projects and global technology initiatives using in-house and CMO resources for all aspects of pharmaceutical drug development. Recognized for stellar ability to achieve delivery of compliant key programs faced with budget and timeline constraints, requiring optimization on several fronts. Dedicated to serving patients and their families facing cancer.