Biography

Kristen Riley, Education & Training Coordinator at the Pharmaceutical Development Institute (PDI), with over 28 years of experience, currently coordinates biopharmaceutical training services for clients in the industry. Ms. Riley is a results-oriented professional with a proven track record in business and operations management, bioprocess component testing and training, marketing, and process/safety engineering. In her current role, Ms. Riley develops workshops, laboratory trainings, and associated instruction of GMP principles and practices in biopharmaceutical sciences. She supports the development and delivery of curriculum that focuses on workforce development for internal/external sources and collaborates with PDI leadership team to conduct strategic growth and management training plans, along with proposal development.

Prior to her current role at the PDI, Ms. Riley served as Principal Engineer of The BioProcess Institute (BPI), managing all daily project activities for the independent testing institute and small business. Ms. Riley ensured that BPI’s major biopharmaceutical clients chose the proper materials for use in their bioprocesses to achieve the highest product quality and optimal process operation, with specific focus on both multi-use and single-use components, where she published several performance reports on the service life of hygienic gaskets and valve diaphragms. She was a project leader for end users and manufacturers and developed protocols, conducted performance tests, and wrote reports. She led analytical projects requiring interpretation of results for compliance with ISO, USP, FDA standards for components, including root cause/failure investigations and extractables studies. In every project, Ms. Riley helped clients understand test results and the implications of the findings and recommendations.

Earlier work included process safety engineering and a role as Laboratory Director of a small environmental laboratory. Ms. Riley is Vice Chair of the International Engineering Program (IEP) Advisory Board at the University of Rhode Island and holds a Bachelor of Science in Chemical Engineering and a Bachelor of Arts in German from the University of Rhode Island, as well as an MBA.