Tissue Operations Specialist

3 semanas atrás

Brasil beBeeOperations Tempo inteiro
Job Opportunity: Tissue Operations Manager

This position is a key member of the team responsible for managing Apheresis and Treatment Centres for CAR T-cell Therapies. As the technical operations single point of contact for designated regions, you will develop relationships with Apheresis, Cell Lab and Treatment Centre Staff to establish apheresis collection footprint.

The role involves coordinating site onboarding activities, performing technical site assessments and training staff on collection requirements. You will also provide Quality Systems support by participating in deviation activities and monitor vendor performance and capacity after site launch.

You will be responsible for managing process changes and rollout at assigned sites, collecting VOC and VOB feedback for continuous operations improvement and entering data into electronic data management systems.

This role requires strong communication skills and experience in Apheresis Operations Management, QA Operations or other relevant areas. The successful candidate will have breadth of experience in regulated environments and understanding of HTA.

Key Responsibilities:

  • Develop Relationships: Establish relationships with Apheresis, Cell Lab and Treatment Centre Staff.
  • Apheresis Collection Footprint: Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprint.
  • Site Onboarding: Coordinate site onboarding activities and ensure sites are prepared within required timelines.
  • Technical Site Assessments: Perform technical site assessments and train staff on collection requirements.
  • Quality Systems Support: Provide Quality Systems support by participating in deviation activities.
  • Vendor Performance: Monitor vendor performance and capacity after site launch.
  • Process Changes: Manage process changes and rollout at assigned sites.
  • Continuous Improvement: Collect VOC and VOB feedback for continuous operations improvement.
  • Data Entry: Enter data into electronic data management systems.

Demonstrated Skills and Competencies:

  • E - Essential:
    • Experience in Apheresis Operations Management, QA Operations, GMP production or other relevant areas.
    • Breadth of experience in regulated environments and understanding of HTA.
    • Successful team-based environment experience.
    • Delivering process improvements in qualification, training and management of external suppliers.
  • P - Preferred:
    • Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
    • Managing contracts with external apheresis providers.
    • Prior customer-facing role in pharmaceutical/biotech industry.

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