Tom Smith
Director, Quality Control @KBI Biopharma
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WORK HISTORY
Director, Quality Control @KBI Biopharma
Responsible for the launch and operations of KBI’s Hamlin site QC department.
EDUCATION
The Johns Hopkins University
Master’s Degree, Biotechnology
Penn State University
Graduate Certificate, Applied Statistics
James Madison University
Bachelor of Science, Biology Major; Chemistry Minor; Pre-Medical Concentration
SKILLS
ABOUT TOM SMITH
Biologics professional with ~15 years of industry experience - 9 years managerial - overseeing the successful launch of GxP teams (pre-clinical through commercial) as large as ~40 personnel.Managerial experience has included oversight of: QC Analytical, Microbiology, Raw Materials, Stability, Technical Services, External CTL and CDMO Management, Client Program Management, Viral Clearance, and interim oversight of Analytical Development. These roles span viral vector based gene therapies (AAV, retroviral, oncolytic adenoviral), cell therapy, monoclonal antibodies, ADCs, AOCs, other recombinant proteins, therapeutic plasmid, RNAi, viral vaccine, toxoid vaccine, and cell banking modalities. Extensive experience representing noted functions for pre-approval inspection (internal and external/regulatory).
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