Analytical Method Development(ADL)

Key Responsibilities:

• Develop and validate analytical methods for drug substances and drug products
• Handle techniques like HPLC, GC, UV, IR, Dissolution, etc.
• Perform method transfer to QC/plant locations
• Prepare protocols, reports, and documentation as per regulatory guidelines
• Support stability studies and impurity profiling
• Ensure compliance with GLP, cGMP, and data integrity norms
• Troubleshoot analytical issues during development and commercial stages
• Work closely with R&D, QA, and manufacturing teams