Chirag Patel
Formulation Development, Process Development, Tech-Transfer, Regulatory Assessment
- Role
- Pharmaceutical Scientist at FDA
- Location
- Mount Vernon, IN, US
- LinkedIn followers
- 500 followers
About Chirag Patel
Dynamic leader with over 15+ years of expertise in pharmaceutical R&D, manufacturing, and regulatory assessments. Extensive experience in developing and commercializing oral solids, oral liquids and Injectable dosage forms. Proven success in technical leadership, scaling up manufacturing processes, and implementing robust control strategies. Adept at supporting regulatory submissions and inspections with comprehensive technical documentation. Recognized Subject Matter Expert (SME) in drug product manufacturing and development with a track record of driving significant organizational improvements and cost efficiencies.
Experience
Pharmaceutical Scientist
Apr 2024 — Present
Oversee scientific assessments and quality evaluations of pharmaceutical manufacturing processes and facilities for NDAs, ANDAs and supplements.• Support pre-approval and cGMP inspections, addressing issues with risk-based approaches.• Provide science- and risk-based recommendations to support regulatory decisions.• Serve as a key technical resource for regulatory and quality compliance.
Education
S.K.B College of Pharmacy, Affiliated to RTM Nagpur University, Nagpur, India
Master of Pharmacy, Pharmaceutics
2006 — 2008
Kadi Sarva Vishwavidyalaya, Gandhinagar
Doctor of Philosophy (PhD), Pharmaceutical Sciences
2010 — 2017
S.J.M. College of Pharmacy, Affiliated to Rajiv Gandhi University of Health Sciences, India
Bachelor of Pharmacy (BPharm), PHARMACY
1999 — 2003
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