Lee B. Bussey, PhD

Chemistry, Manufacturing, and Controls

Lee B. Bussey is an expert in microbial genetics/physiology along with more 27 years of experience in process development, manufacturing, technology transfer, and scale-up to meet commercial markets.  He has expertise in large scale plasmid DNA purification for both gene therapy and immunotherapeutic. In addition he has experience with a number of protein expression systems… Read More »

Michiel Ultee, PhD

Chemistry, Manufacturing, and Controls

Michiel E. “Mike” Ultee has held positions of increasing responsibility in research, development and manufacturing in the biopharmaceutical industry since 1983. Prior to consulting full time in 2015, he served as Chief Scientific Officer for Patheon Biologics, before then Gallus Pharmaceuticals and Laureate Biopharma.

Rebecca Dabora, PhD

Chemistry, Manufacturing, and Controls

Rebecca Dabora is a CMC expert with 27 years of experience in the development of clinical and commercial stage biopharmaceutical products.  She is currently an independent consultant and has been providing CMC and program management support for the past 15 years to numerous biopharmaceutical client companies. Previous affiliations include Altus Pharmaceutical, Biogen, Inc. and Merck.

Amy Dingley, PhD

Quality Control & Quality Assurance

Amy Dingley has thirty years of experience in Analytical Development and Quality for the biopharmaceutical and medical device industries. Expertise includes clinical and commercial product support, regulatory filings, health authority site inspections and manufacturing facility validation and support. Previous affiliations include Biogen Idec, Stryker Biotech, and Olympus Biotech.