Katherine L. McKinney, PhD, MS, is a Technical Writer and Biochemical Engineer with 11 years of pharmaceutical industry experience. Her background includes preparation and filing of Chemistry, Manufacturing, and Controls (CMC) sections of international regulatory documents (BLAs and INDs) leading to licensure of vaccines or approval to conduct clinical trials as well as an NDA currently under review. Ms. McKinney is a consultant at Hemispherx Biopharma, Inc. (New Brunswick, NJ) preparing CMC and process validation documents. Prior to that she worked at Merck Research Laboratories (West Point, PA) in Bioprocess Research and Development as a Senior Research Biochemical Engineer and Technical Writer. Ms. McKinney earned both her PhD and MS in Chemical Engineering at Rensselaer Polytechnic Institute. She completed her undergraduate work at Columbia University earning a BS in Bioengineering.

Update on her biography: Katherine has worked as a part-time consultant on and off for the last several years, primarily writing CMC sections for New Drug Applications (NDAs) as well as process validation documentation. She is caring for three children between the ages of four and nine, so she plans to continue being a consultant for another two years until all of them are in school for the full day. She states, “The FDAAA scholarship was a great help in allowing me to continue my education in the QA/RA program at Temple. The QA/RA program has helped me to stay current in my field and be able to do the kind of consulting work that I enjoy. The faculty has been outstanding and extremely knowledgeable. I’m looking forward to learning more over the next few years as I complete my Master’s degree and transition back to full-time work.”