Alan Colborn
Executive Director at Organon
Based in Durham, United States
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Seniority
C-Team
Department
General Business & Management
Location
Durham
Industry
Pharmaceutical Manufacturing
Company size
7.4K
Contact information
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a•••••••@organon.com
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Background
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) ascolborn@gmail.com
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