By - February 02, 2021
Not every laboratory professional works in a traditional laboratory setting. This month, Critical Values is exploring roles that medical laboratory scientists can play outside the lab. We talked with Krista Urchenko, MPH, BSc, MLT, a regulatory compliance officer at Health Canada in Ottaway, Ontario. You may also know her from her online presence as @MedLabMaven on Twitter, where she highlights laboratory professions. Critical Values asked her a few questions about her career path, and the role she plays in the medical laboratory community.
Krista Urchenko (KU): I received my Bachelor of Science degree in microbiology with a minor in chemistry from the University of Manitoba. During my studies I focused on microbial disease and molecular biology, and so I had a lot of laboratory experience in molecular techniques. I then received an Advanced Diploma in Medical Laboratory Sciences from the Michener Institute and a Master’s in Public Health from the University of Waterloo.
KU: I’ve always been interested in the laboratory and diseases. Microbiology in particular has been a passion of mine since a young age. I have a photo of myself at seven years old holding a microscope I’d received as Christmas gift! I remember taking out books on meningitis from the library during grade six. I think it was a foregone conclusion at that point! It satisfies my scientific knowledge while also being able to make an impact on the health of a patient and the world.
KU: I initially worked in a private lab working in Histology but quickly transitioned to working in specialized microbiology at a provincial public health lab. After being with the lab for a few years, I completed my Master’s of Public Health, which opened my eyes to a lot of other areas where my laboratory expertise can make an impact.
KU: Currently, my job title is Corporate Regulatory Compliance and Enforcement Advisor in Drug Good Manufacturing Practices. I work to establish and enforce regulations and guidance around GMP principles for drug manufacturing including biologics and radiopharmaceuticals. Specifically, I will be working on our Advanced Therapeutics program, which will encompass many clinical labs doing specialized and personalized medicine. Drug GMP is a huge program with lots to learn and a lot of intricacies. Coming from a highly regulated lab background has given me a lot of insight and knowledge of how to apply regulations and where there may be room for improvement to protect the public.
KU: It’s looking a lot different now that we are working from home [because of the pandemic]! No day is the same. Generally, I work on my research projects, policy documents or guidance documents. I am frequently in meetings with colleagues within my unit and also cross-functional teams from other directorates and even branches.
I also engage with external stakeholders including preparing documents for consultations and responding to questions. Once travel is on again, I will attend conferences to present our organizations positions and updates to GMP guidelines as well as give internal training to our inspectors.
KU: Part of my responsibilities involve the production of biologic products and advanced therapeutics which plays directly into my background. Knowing the risks from performing laboratory testing translates directly into how cell products are manufactured and how to perform it while applying quality management principles.
Many medical laboratory scientists are involved in processing these products on the next frontier of medicine like CAR-T cells and genetic engineering for personalized medicine. I’m really excited to be able to bring my knowledge to these guidelines as I speak the same language as people who will be manufacturing the products and believe I can create a solid program to help advance medicine.
KU: Sometimes I miss bench work. There is something so satisfying about being able to test patient samples and seeing the fruits of your labor in a few hours (or days). Working on research projects and policy is much more of a long haul so it can take longer for the pay off!
Laboratory professional, web editor of Laboratory Medicine magazine and editor of Lablogatory