BACKGROUNDPharma, medical device, and combination product experience. Worked as Individual contributor in technical, quality, and regulatory functions. Managed U.S. and global teams. Built operations (R & D and scale-up manufacturing) departments. Supported quality, clinical studies, and regulatory submissions in both U.S. and EU. Product categories have included drug release, ophthalmology, medical aesthetics, reconstruction, wound healing, and inkjet printing. Built operations infrastructure involving staffing, lab and facility lay-out and build, and systems and procedures. Conducted product development activities in all size organizations, from early-stage to large cap. Enjoy building relationships with staff, KOL’s, and suppliers. Adept at critical thinking, strategic planning, and problem solving.EXPERIENCETechnical: CMC, medical device, combination product, biomaterials (synthetic and biological), , fabrication, delivery devices, analytical testing (chemical, physical, biological), animal studies, ISO 10993 biocompatibility.Corporate: Budget & finance, business development, team leadership & management, domestic & international teams, in-licensing, out-licensing.Functional Activities: R & D, Operations, Pre-clinical, biocompatibility ISO 10993, scale-up, manufacturing, supply chain, quality, project management, IP, clinical support, troubleshooting, FDA & EU MDR registration.Product Categories: Drug release, wound healing, ophthalmic implants, eye drops, spinal injectable, contact lenses, tissue integration, medical aesthetics (dermal fillers, breast implants), bariatric, packaging, inkjet.EDUCATIONPh.D., Chemistry | University of California – San DiegoB.S. degrees in Chemistry and Biology | U. of Wisconsin - Eau Claire