Manager

• Oversee, manage and coordinate end to end Drug product manufacturing and packaging oversight at CMOs
• Serves as the point of contact, technical lead in leading oversight and management of external contract development & manufacturing organizations (CDMOs) for commercial needs
• Actively manages CDMOs in assigned projects to coordinate technology transfer and development efforts per project milestones, timelines, and deliverables for projects
• Reviews and coordinates Quality related documents pertaining to production with CDMO’s
• Responsible for implementation and maintenance of serialization systems to ensure compliance with regulatory requirements
• Responsible for collecting, reviewing and compiling operational data to track key performance indicators (KPIs)
• Assists in coordinating release and stability tests for drug product manufacturing and packaging
• Develops specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues

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