Timothy M. Kelly

Biography

Tim began his tenure at KBI in 2005, initially acting as Vice President of Biopharmaceutical Development where he led the establishment and growth of KBI’s analytical development, formulation development, and cGMP laboratory services business. He subsequently served as Executive Vice President of Operations with responsibility for KBI’s development and manufacturing functions in North Carolina and Colorado. Tim has overseen biopharmaceutical services for over 320 molecules at all stages of development and commercialization and has supported numerous successful FDA and international regulatory inspections throughout his career. Tim’s previous experience includes directing the quality control function for Diosynth Biotechnology, where he supported clinical and commercial biopharmaceutical products. Tim has over 20 years of experience in large molecule development and characterization. He earned his Ph.D. in Molecular Genetics & Biochemistry from Georgia State University. 

Research Interest

The company offers services in the areas of formulation development, analytical method development and testing, protein and particle characterization, mass spectrometry, modeling and simulation, release testing and stability, cell line development, process development, process characterization/scale-down validation, technology transfer, and cGMP manufacturing aspects; and chemistry, manufacturing, and control submission aspects