Bio

• Accomplished technical and organization leader with 10+ years of professional experience in biologics development including sterile drug product and process development, aseptic processing, technology transfer, manufacture in cGMP, and life cycle management • Experience in driving clinical and commercial product strategy through leadership roles on drug product, technology transfer, broader CMC, and due diligence teams • Track record of successful development of broad set of biologics dosage forms for pre-clinical to commercial products including, technical leadership, resource projection and planning and defining product development strategy • Experience in tech transfer to internal and external manufacturing sites in support of clinical and commercial product manufacture – including due-diligence, negotiating QTAs, project planning and management, facilitating technical development, interfacing with quality organization on deviations, investigations and CAPAs • Delivered US and ex-US regulatory submissions • Hired and managed staff of 10+ direct reports including associates, scientists, and process engineers • Core areas of expertise: aseptic processing, process engineering and scale-up, sterile product and process development, technology transfer, drug product manufacture, building high functioning teams