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Cell Therapy Operations Director
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The primary responsibility of this CTOM role is to lead regional onboarding, continued operations, and maintenance of CAR-T centers in compliance with local health authority and internal regulations.
Ensuring timely supply of high-quality starting material for manufacturing personalized CAR-T products and providing seamless end-to-end operational customer support.Key Responsibilities:
- Manage CAR-T center operations, coordinate key staff, ensure safe and efficient patient treatment, and lead continuous operations improvements.
- Guide trial site selection, set up new ways of working, ensure site readiness, and manage CAR-T center operations to ensure proper timelines and quality standards.
Center Qualification: Lead onboarding of CAR-T centers, support site selection, and drive consistent rollout of site training plans.
Center Operations Excellence: Ensure high-quality supply of human cells and tissues, drive site maintenance, and lead continuous operational improvements.
Deviation Management: Evaluate, investigate, and document issues related to cell collection, handling, or processing, and provide feedback and training to improve outcomes.
Key Performance IndicatorsGuarantee proper CAR-T site network through effective onboarding and site maintenance. Deliver operational projects on time and reduce deviations. Support customer satisfaction and success of manufacturing.
Impact on the OrganizationThis role will significantly impact ensuring safe and effective use of Novartis Cell & Gene therapies by treatment centers.
Ideal BackgroundEducation: University degree in Science, Medical or Nursing (bachelor's degree minimum).
Experience: Several years in external partner-facing roles or leadership in healthcare, with experience in hospital stakeholder management, pharmaceutical or hospital GxP environment, and project management.
Skills: Strong communication, emotional intelligence, business acumen, negotiating and scientific skills, and ability to operate in high technology environments.
Languages: Preferred: One other language (e.g., Korean or Chinese)