Lead and execute Analytical Method Development, Validation and Method Transfer for API and finished formulations including Solid/Liquid Orals and Injectables.
Handle analytical activities for both Drug Substance and Drug Product development projects.
Provide analytical support for method-related troubleshooting, investigations and laboratory incidents/deviations.
Plan and execute analytical projects in coordination with R&D;, QA, QC, Regulatory Affairs and other cross-functional teams.
Prepare and review validation protocols/reports, STPs, specifications, SOPs and investigation reports.
Ensure analytical activities comply with cGMP, GLP, ICH guidelines and applicable regulatory requirements.
Support and participate in regulatory inspections/audits, including USFDA.
Review analytical data and ensure timely completion of projects as per defined timelines.
Drive day-to-day ARD activities, resolve technical issues and provide guidance to team members.
Ensure effective coordination and communication across functions for successful project execution.

📌 Assistant Manager Deputy Manager Manager Analytical R&d Ard Haridwar
🏢 Themis Medicare
📍 Haridwar