Microbiologist Enjoying Second Career with FDA

When I moved to Colorado seven years ago, I never dreamed I’d find such a great new career! I had been a secondary science teacher in Mesa, Arizona for 16 years encouraging students to develop a love of science and to pursue careers in science. Then, in 2002 I was hired by the U.S. Food and Drug Administration Denver District Laboratory as a counter-terrorism hire to help protect the American public health. Suddenly I became a working scientist doing all the cool things I had told my students they could do one day if they pursued a career in science!

I was hired along with nine scientists and we now make up part of a team of eighteen microbiologists in the Denver District Laboratory. No matter what our specific backgrounds, we were all trained the same way that first year. Our laboratory trained us in teams of two and the agency trained us as well in basic microbiology, FDA law and evidence, and regulatory science. It was a steep learning curve, but it was all so exciting and new. Over the course of the last five years, each of us have also been trained in specialty areas – such as sporicidals, LAL (endotoxins), and sterility – by GS-13 specialists. (A GS-13 specialist represents the highest level of expertise in the district for areas involving drugs, devices, biologics, sporicidals, biotechnology, or in vitro devices, etc. As an expert in analytical problem solving relating to microbiological analysis, the specialist is called on to examine those samples that require the application of the most difficult methods or those samples for which no method exists.) The opportunities have been great and the senior analysts have always been there to help us grow and learn as regulatory microbiologists.

I have also been trained in some investigative work and occasionally get out of the lab to assist in inspections with one of our consumer safety officers. One inspection was at a firm making cosmetics with sunscreen, which are considered OTC drugs. I looked at the laboratory and its Quality System to ensure compliance with the Food, Drug, and Cosmetic Act. We also looked at the firm's use of Current Good Manufacturing Practices to ensure that the product was not adulterated. I enjoy participating in inspections of laboratories in facilities that we regulate and look forward to doing more of those team inspections in the future.

My work is varied and never dull. I analyze domestic and import samples of foods, drugs, medical devices and cosmetics for microbiological contamination. It is a good feeling to know that when I find a volatile sample, that particular product will not reach a consumer. There can be no greater calling than to protect the public health.

We all work as a team in our lab, often coordinating and sharing the use of equipment or working on collaborative research projects together. The opportunities for research and additional training are always there, and when I was studying for the Consumer Products and Quality Assurance test in Food and Dairy, I could count on the senior analysts and the chemists for help in understanding areas where I was weak. My supervisor has always encouraged me in my quest for more training and knowledge and several of the senior analysts have served as my mentors, helping me to reach the journeyman level (GS-12) and beyond.

I would encourage young microbiologists to continue gaining expertise, additional training, and participating in professional organizations as a means of keeping current and sharp in their chosen field. For me, a love of learning and a love of science are life-long pursuits and the rewards of public service are immeasurable.

Patricia Stahnke became certified by the NRCM in 2005, and joined the NRCM Consumer Products and Quality Assurance Microbiology Exam Development Committee in 2006. She lives in Lakewood, CO.

Copyright© National Registry of Certified Microbiologists. Reprinted from The Loop, 2007, Issue 2.