Title: Head of Clinical Testing and Development Laboratory
Company: Takeda Vaccines
Location: Longmont, CO United States
Initially, Dr. Mary Kathryn Smith began her career as a social worker working with developmentally-disabled clients. During this time, she found that a lot of the disabilities could be traced back to infectious diseases. Realizing she wanted to help stop the impact of said diseases, she decided to go back to school to earn a Ph.D. in microbiology and immunology. She was a graduate student at the University of Colorado Health Sciences Center from 2003 until 2008, at which point, she became a senior fellow at the University of Washington. One year later, she became a postdoctoral fellow at National Jewish Health, and in 2012, she landed her current position as the head of clinical testing and development laboratory at Takeda Vaccines.
For the past four years, Dr. Smith has been responsible for hiring, training and supervising all laboratory scientists, as well as collaborating with global cross-functional teams to create scientific strategies for clinically relevant method development, transfer and validation. She also works to ensure internal and external compliance with the FDA, ICH and WHO guidelines, and provides data packages, review and feedback for domestic and international regulatory filings. She must also develop and maintain strong, positive relationships with external partners. She is very proud of the work she has done to help make people’s lives better. In fact, one of her greatest career achievements so far has been working on the vaccine to prevent the dengue virus up to the third phase.
Looking to the future of her career, Dr. Smith hopes to create a network of science professionals that are dedicated to educating the public, as well as bridging the communication gap between researchers and non-science professionals. In addition to her work with Takeda Vaccines, she is also associated with ASTMH, ASV and AWIS.
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