Hello, I’d appreciate some feedback on my profile for potential O1 or EB1A petitions. I’m a Project Manager in the pharmaceutical CDMO industry with about 9+ years of experience in drug development, regulatory submissions (IND/NDA/ANDA)and GMP commerical manufacturing operations.
Background:
• Education: M.S. in Chemistry
• Certifications: PMP certified
• Experience: 9+ years across major CDMOs, Pharma industry
• Current Role: Leading multimillion-dollar client projects ($50M+), responsible for tech transfer, CMC strategy, and regulatory documentation.
Academic / Technical Work: •
Publications: 1 peer-reviewed publication so far; 3 more in submission (as second author for 2 review papaers and one book chapter).
•Patents: 3 design patents approved and 1 pending in India
•Posters: Multiple poster presentations at industry conferences (AAPS, university level, IPC). •Peer Review: 12 review papers with three journals and 4 poster review.
Achievements:
•Led multiple IND/NDA/ANDA filling projects.
•Improved GMP efficiency and compliance through digital project management tools.
•Collaborated directly with U.S. and European pharma clients and regulatory bodies.
•Part of process innovation and tech transfer initiatives across multiple drug platforms weight loss, cancer treatment.
Memberships: • AAPS, PMP, Contract Pharma, Drug Development and delivery.