Bio

An accomplished industry leader with broad experience that encompasses early process development to commercial operations, strategy development and implementation. Company experience includes from start-ups to established biopharmaceutical organizations. Regulatory experience: versed in US-FDA, EU-EMA, PIC/S regulations, ICH and NIH Guidance. Have been working in depth in the (bio)pharmaceutical industry for 29+ years and am involved in all levels and aspects of Design, construction oversight, manufacturing, regulatory, qualification and process validation, regulatory interface and submittals, operations, financial planning, development of drug substance and drug products, Scale-up, and technology transfer (internal and external). - Designed, constructed, and qualified projects in all scales (small and very large-$$$$) - Provided planning and implementation services for very large sites around the globe - Performed audit and gap analysis and risk based management - Provided services for clients on CMC, BLA, MAA, preparations and submittals - Managed contracts, CAPEX for many clients on many projects - Provided oversight, procurement and program management for clients internationally