Kellee Darnell
Bio
Principal Process Engineer at CSL Behring
B.S. Chemical Engineering
M.S. Chemical Engineering
Kellee has 14 years of professional engineering experience with 11 years of it being in the biomedical/pharmaceutical industry. She has worked with pharmaceutical products, medical devices and combination products. She has been involved in almost every stage of a product's lifecycle from R&D and proof-of-concept prototype to qualification/commissioning/validation to manufactured product and continuous process verification. Kellee has been responsible for process/design improvements, design/technology transfers, product/equipment reliability, risk mitigation and establishing critical process parameters and controls while complying with EPA regulations, FDA regulations (cGMP), OSHA requirements, IEC guidance and ISO standards.