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