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Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is well-versed in the FDA and rest of world drug and combination product regulations. His focus has been to develop the right product based on strong requirements to the patients to improve their lives.

As a pharmaceutical product developer, Expert has gained much experience in several areas. These include drug and excipient material science, specification setting, CRO and CMO management, active pharmaceutical product ingredient analytical sciences, drug delivery, formulation development and process development. As a six sigma black belt, Expert is always looking to improve the way business is performed, improving processes and eliminating waste.

In his product development role, Expert has written and reviewed CMC (chemical, materials and controls) sections of NDAs (new drug applications) for several drug delivery products, including oral, implantable, transdermal and electrolytic transdermal therapies. He has developed raw material portfolios for these type products, linking key materials to product requirements to insure their suitability for use. By setting relevant specifications and working with suppliers to maintain these specifications, Expert developed high reliability processes for the development projects.

He is also well versed in the regulations surrounding drug development, particularly on the materials, drug ingredients, drug products and quality areas. He recently took a class in "Interacting with the FDA". He keeps abreast of new requirements for the cGMP regulations, and is particularly adept at dealing with both the drug and medical device requirements for combination products.

Expert's original degree and work experience was in analytical chemistry, and he has expertise in analytical instrumentation and methodologies, particularly pertaining to drugs. He has a speciality in a subset of HPLC, ion chromatography. He has developed instrumentation and test methods for IC, while working for the market leader in the sector. He also has expertise in wet chemical analytical methods, polymer rheology and viscometry, physical test methods such as tensile testing and adhesive testing, and various forms of spectrophotometry.

Expert holds a six sigma black belt in process development and improvement. He has led several projects that have eliminated waste and improved the way processes are performed. These projects included drug excipient manufacturing development, electronic component manufacturing, and financial process business improvement. He has also mentored several six sigma green belts and taught six sigma tool methodologies to team members.

As a six sigma practicioner, Expert is not dogmatic about tool usage as many other practicioners are. Rather, he espouses a softer approach, where the tools are used as indicators and aids to really understand the root cause of problems and come up with achievable solutions. He is a big proponent of setting metrics to assess and measure the health of processes, and to take a big picture view of what's actually happening in the processes.

Expert has worked with a medical device company developing products for personalized medicine. He helped them assess skin adhesive chemistries, bioerodible films, and the chemical systems in their products.