
Assistant general manager leading analytical method development for finished products and dosage forms across a 15-member team. Delivers dissolution, related substances, assay, residue analysis, and uniformity of dosage units work under USFDA and ICH guidelines, with method transfers and troubleshooting for multiple locations. Approves development reports and coordinates working standard qualification with cross-functional teams and external partners.
Analytical method development
Method transfer
Dissolution testing
Related substances analysis
Assay development
ICH guidelines
USFDA compliance
Method validation
Working standard qualification
Analytical troubleshooting
Team leadership
Report approval
Cross-functional coordination
Resource management
People management