Maria Oyaski MS, MA, RAC (US,EU)

Product Development Champion

Maria Oyaski is a product development champion at Facet Life Sciences. Originally from Western Pennsylvania, she is now firmly entrenched in the “City of Medicine”: Durham, North Carolina (the town built by and for tobacco – see, progress is possible!)

Maria spent far too long in school, including the University of Pittsburgh for a BS in Biological Sciences and an MA in History and Philosophy of Science (yes, really!), and then to the University of Pennsylvania for an MS in Cell and Molecular Biology; along the way she accrued a decade of experience as a bench scientist in cell and molecular biology. She continues to be a voracious lifelong learner and science nerd. She also really likes to tell stories (nonfiction only!), and is a frequent invited speaker on regulatory topics – especially, on understanding what FDA wants, and why they want it, and on how tomatoes can teach you most of what you need to know about analytical validation of test methods.

Her experience in industry has included roughly a decade as the regulatory strategy and operations lead for sponsor companies developing novel advanced therapies (complex engineered cell therapies) and diagnostic systems, which also included significant medical writing and quality assurance experience. However she has also spent time on the CRO side of the fence, with direct experience in regulatory, clinical research, and pharmacovigilance (drug safety) roles. She has extensive experience in immunotherapies for various cancers, and diagnostics for infectious diseases, with additional experience in Type 1 diabetes and other immune disorders, HIV, cardiovascular disease, contraception, and more.

Maria sees her work in regulatory affairs as serving as a translator and diplomat (i.e. storyteller) between the scientists who develop great new medical technologies, and regulatory agencies carrying the enormous responsibility of judging whether these technologies may enter the market. Often this work as an agency liaison entails coaching discovery staff on how to do development science – i.e., understanding what FDA wants, and why they want it, and how we can meet their needs.

When not working to figure out a path that will make sense to bring some great new medical technology to market or preparing yet another talk, Maria spends her time enduring the learning experience of having teenage daughters – or, she and the hubby might go out to some great new Durham restaurant that the girls would not appreciate. She does occasionally pound hammers and lift heavy things with Habitat for Humanity, perpetually attempts a tomato and herb garden, and anesthetizes feral cats for spay/neuter operations at Independent Animal Rescue. With the latter, she has implemented several process improvements at the feral cat clinic, inspired by her experiences in quality assurance for manufacturing of complex cell therapies – especially in the areas of labeling, documentation and cleaning. So far she has only been bitten once and that was her own stupid fault – another learning experience for continuous improvement!