Key Responsibilities

Technical Operations & Process Excellence

• Lead scale-up, engineering batches, PPQ batches, process validation, and technology transfer activities.
• Review and approve validation protocols, reports, and batch manufacturing records.
• Drive process optimization, troubleshooting, revalidation, batch size changes, equipment changes, and alternate vendor development.
• Act as SME for process-related deviations, OOS, CAPA, change controls, and investigations.
• Ensure effective risk assessments and continuous process improvement initiatives.
• Support facility and equipment qualification activities.

Manufacturing Network Strategy & Planning

• Lead capacity planning and RCCP activities to align demand with manufacturing capabilities.
• Identify manufacturing constraints and implement mitigation plans.
• Review forecasts, pro...