Steve Kornher, PhD

POUGHKEEPSIE, NY Steve Kornher, PhD SENIOR CONSULTANT, REGULATORY CMC

John Stephen Kornher has more than 30 years of experience in Quality Control and Regulatory CMC. His experience includes the preparation of Module 3 of the CTD and health authority meeting documents for early-stage stem cells, recombinant protein, plasmid, nucleic acids, and oligonucleotide therapies. Steve has deep experience in preparing CMC-related documentation for comparability assessments, stability programs, method transfers, etc., and conducting critical gap assessments. Steve has managed CDMOs’ drug substance manufacture, fill/finish, analytical method development, quality control, and quality assurance activities. 

Before joining Halloran, Steve was responsible for the Quality Control and Quality Assurance programs for Semma Therapeutics (now Vertex Cell and Gene Therapy), an early-stage stem cell company. Before Semma, Steve was a Regulatory CMC consultant at IQVIA. Earlier, Steve served as VP of Quality Control at Mesoblast with responsibility for managing all aspects of the Quality Control program for their early-stage stem cell therapy. Earlier in his career, Steve held multiple positions as a Regulatory CMC, Quality Control, development, and manufacturing. 

Education:

Bachelor’s Degree in Mathematics, University of California Berkeley 
Ph.D. Biology, University of Pennsylvania 
N.I.H. Postdoctoral Fellow, Dept. of Biochemistry, Stanford University 
Howard Hughes Medical Institute Postdoctoral Fellow, Dept. of Biochemistry and Biophysics, University of California San Francisco