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Lead the development, validation, and transfer of analytical methods, including troubleshooting cleaning validation challenges. Provide technical oversight during tech transfers, process validation, and commercial manufacturing phases to monitor production and analytical outcomes. Author and review critical laboratory documentation, including method protocols, SOPs, calibration procedures, and analytical test records. Execute raw material, intermediate, and stability testing while overseeing sampling protocols for utility systems like water, nitrogen, and steam. Lead laboratory investigations, troubleshoot equipment issues, and champion continuous improvement via Lean Six Sigma initiatives. Manage laboratory instrument calibration and maintenance to ensure full regulatory and operational compliance.
Job Responsibility
Lead the development, validation, and transfer of analytical methods, including troubleshooting cleaning validation challenges
Provide technical oversight during tech transfers, process validation, and commercial manufacturing phases to monitor production and analytical outcomes
Author and review critical laboratory documentation, including method protocols, SOPs, calibration procedures, and analytical test records
Execute raw material, intermediate, and stability testing while overseeing sampling protocols for utility systems like water, nitrogen, and steam
Lead laboratory investigations, troubleshoot equipment issues, and champion continuous improvement via Lean Six Sigma initiatives
Manage laboratory instrument calibration and maintenance to ensure full regulatory and operational compliance.