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, production schedules, and site commitments to ensure timely product supply.
- Drive production scheduling, resourc...