Executive Director
• Eighteen years of experience in biotechnology manufacturing, with an emphasis on translating early-stage therapeutics into the clinic
• Developed nine IND-enabling cGMP processes on both cell therapy and microbial derived proteins, one of those products was successfully scaled to support Phase III clinical studies
• Successfully completed the build out and GMP preparation of the Gates Biomanufacturing Facility
• CMC and regulatory experience for multiple autologous and allogeneic cell therapy processes
• Considered a world expert in protein refolding