Daniel Kirschner

Executive Director, Analytical and Biopharmaceutical Services
Durham, NC, USA
“I love chemistry: Being in the lab and having an opportunity to see and study new molecules every day. I think of chemistry like a puzzle with new pieces getting shuffled into the pile. We’re constantly trying to find new ways to solve the puzzle utilizing the core principles of chemistry. That’s why I embrace every chance to look at a new chemical process and try to figure out the analytical controls around that process.”


Daniel combines his passion for chemistry with strong leadership and problem-solving skills to progress the development of new drug therapies.


  • Ph.D. from the University of Alaska Fairbanks in bioanalytical chemistry
  • Scientific leader with nearly 15 years of pharmaceutical experience (biotech and CDMO)
  • Experience in all stages of clinical development from pre-IND through to registration
  • Author of multiple manuscripts in analytical and organic chemistry and holds several patents
  • Responsible for all aspects of CMC analytical support

Areas of Expertise

  • Analytical and organic chemistries leading to method development, validation, transfer, quality control, impurity ID, and trace quantitation supporting CMC programs for drug substances and products
  • Experience authoring CMC sections for IND, IMPD, and NDA and routinely participating in audits
  • Training programs and SOPs for developing talent in highly regulated environments
  • Stability studies, instrument calibration, CRO/CDMO management, and process improvement
  • Lean Six Sigma Green Belt