I hold a PhD from the University of Michigan in Macromolecular Science and Engineering as well as 20+ year industry record of concept-to-launch success within challenging drug-device combination product systems. I am currently transitioning my vast industry experience into a consulting practice with focus on 4 core services:FORMULATION SCIENCE I manage formulating, analytical testing, process development, and manufacturing – the chemistry and manufacturing control (CMC) system. I have a vision for what the FDA and EMA need in the regulatory filing. I put the pieces of the story together so the filing (IND, NDA, or CTD) shows the FDA or EMA that the product is well understood and safe for patients. I also manage from Clinical Phase 1 through commercialization, with clearly understood and tested changes to the product or the process. CMC TEAM LEADERSHIP AND CMC REGULATORY I am an enthusiastic CMC team leader. I have assembled and managed CMC teams in both large and small companies. My style of management encourages transparency and responsibility. I develop teams that are passionate about their contribution to the project. The guiding beacon for the team is always the regulatory filing. I develop a strategy for what pieces will go into the CMC sections, what questions might be asked by authorities, and what is phase appropriate. I represent the CMC team in meetings with regulatory authorities and devise concise responses.R&D OUTSOURCE MANAGEMENT CONSULTANT I outsource pieces of the project and manage vendors. I use companies’ expertise and equipment to benefit the project. I identify the right contractors, building and managing relationships, and managing costs/timelines. I also source raw materials and packaging needed for the project. On the other end of the spectrum, when in-house capabilities need to be increased, I source new equipment and laboratory space. SUSTAINED RELEASE IMPLANTS My expertise is sustained release implants, such as when drug needs to be delivered to a specific area of the body for an extended period of time. My main experience is with ocular implants and vaginal drug delivery, but the concepts are applicable to other areas, such as subdermal and transdermal delivery systems. I am considered a subject matter expert in these complex areas and I’m often requested to give my scientific opinion that guides the project.My scientific background blended with my project management skills and my authentic and servant leadership approach maximizes the value I bring to companies for best-in-class results.