Alan Colborn
Executive Director Analytical Operations at Dermavant Sciences
- Role
- Executive Director at Organon
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Alan Colborn
I am a scientific leader in the pharmaceutical industry. Specialties include: Development, QA/QC and Manufacturing. Lead Pharmaceutical Development matrix teams. Supervised the start-up and operation of analytical laboratories. Experienced with regulatory requirements for IND and NDA, FDA submissions/reviews and regulatory agencies in Europe, Asia, and Australia. Interact with supervisory chemists and field inspectors for post approval change requirements. Analytical methods development and validation for drug substances and products. Process validation and troubleshooting of solid dose, semi-solid topical, and inhaled products. Led Chemistry, Manufacturing, and Control (CMC) teams Product registration in US, Europe, and Japan Manufacturing process and Analytical methods development and validation, and transfer FDA Inspections (Pre-approval and general GMP) a••••••••@gmail.com
Experience
Executive Director
Nov 2024 — Present
Education
Indian River State College
A.A, Science
1975 — 1977
Duke University
Ph.D., Analytical Chemistry
1980 — 1985
University of Central Florida
B.S., Chemistry, Forensic Science
1977 — 1980
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