Demonstrated balance of technical expertise, business acumen and strong cross functional leadership developing and leading large organizations in a global cross cultural environment. Broad based technical expertise in upstream and downstream bioprocessing, sterile formulation and filling unit operations including assessment and introduction of new technologies. Significant experience with regulatory filings, pre-approval inspections and FDA interactions. Adept at strategic thinking, collaboration and influencing at all levels, change leadership and proven ability to coach and develop people and organizations with technical excellence and business focus. Proficient at leading complex projects from product / process development, scale-up, conceptual design and engineering through internal and external manufacturing demonstrations, validation, product licensure and continuous improvement. Effective at championing and utilizing lean six sigma methodologies (six sigma green belt certified) for incorporating customer value propostion during product / process development, continuous improvements, technical problem solving and business process optimization.