Assistant Manager Deputy Manager Manager Analytical R&D ARD

Themis Medicare Limited; Haridwar; On-site; INR 900,000 - 1,800,000; Full time

Job summary

Themis Medicare Limited in India is seeking a senior analytical scientist to lead and execute Analytical Method Development, Validation and Method Transfer for API and finished formulations, including solids, liquids, and injectables. You will work across Drug Substance and Drug Product development and ensure cGMP and ICH compliance.

You will coordinate with R&D, QA, QC and Regulatory Affairs, prepare validation reports, STPs and investigations, support regulatory inspections (USFDA), review

Responsibilities

• 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.

Job description

• 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.