Lee McDonald

College of Saint Benedict/Saint John's University Alums

Class of 1984 Saint John's University Alumni

Associate Director of R&D for Analytical Methods Validation
Ortec International, Inc., NY, NY

Lee McDonald writes:

I've been thinking of writing for some time now, just to get the faculty caught up on my education and career. With very fond memories of my undergraduate education, especially the classes in general chem, equilibrium chem, and analytical chem, I'm glad to say that I'm a practicing analytical chemist at this time.

I received a Ph.D. from Wright State University in 1989, in Biomedical Sciences, performing my dissertation work on the purification and characterization of a mammalian enzyme. Following that I spent my post-doctoral training at the NIH, from 1989 to 1994, working on post-translational regulatory modifications in proteins. After probing for jobs in academia and industry, I decided to begin my career in the biotechnology industry, working at Molecular Geriatrics in suburban Chicago from 1994 to 1995 as a research scientist in nitric oxide biochemistry and drug discovery of nitric oxide synthase inhibitors. After this I spent from 1995 to 1998 as a research scientist at IIT Research Institute, an arm of the Illinois Institute of Technology in Chicago. This was an interesting job where we performed contracted research for the chemical and pharmaceutical industries, and also competed for government grants and contracts. My work included analyses of dosing formulations and diets, and bioanalytical studies of xenobiotic metabolism in in vitro and in vivo models. I maintained a real research program in nitric oxide and stress-related cellular responses, with a small NIH grant.

My career has taken a happy, definitive turn in my present position, as Associate Director of R&D for Analytical Methods Validation at Ortec International, Inc. a biotechnology company in NYC. Here I direct a staff of 8 in the development, validation, and transfer of analytical methods to the QC department, and in the performance of support work for other company departments. We are a tissue engineering firm that is about to receive FDA approval for the marketing of our first product, Composite Cultured Skin, a living medical device composed of human keratinocytes and fibroblasts growing inan engineered collagen matrix. The work at this company is incredibly wide-ranging and interesting, and everything that I have learned from college onward is put into use here. The scope of work includes developing in vitro and in vivo biological assays for product performance, assays for the acceptance and performance of biomatrix materials, assays for raw material acceptance, ID, and stability, and more.

Beginning next year, I will also be teaching at Adelphi University in Garden City, NY in the Chemistry and Biology departments. The first class is introductory toxicology for the chemistry department. The second class I am developing from scratch, on the topic of Industrial and Regulatory Biology. This will be a career-oriented class in preparation for entering work in the FDA-regulated industries.

On the home front, I am married to Ginger Johnson, a Ph.D. scientist who has changed career directions into the business world. We live in suburban New Jersey with our son Collin, 3.

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