Tissue Operations Expert

Há 2 dias

Fortaleza, Brasil beBeeOperations Tempo inteiro
Job Title

The Tissue Operations Manager oversees the management of onboarding and ongoing performance of Apheresis and Treatment Centres for CAR T-cell therapies.

This role serves as a technical operations single point of contact for Apheresis and Treatment Centres within a designated region, developing relationships with Apheresis, Cell Lab and Treatment Centre Staff.

  • Establishes apheresis collection footprint through collaboration with Clinical and Commercial CAR-T teams.
  • Coordinates site onboarding activities and prepares sites for collections.
  • Communicates on-boarding status and develops mitigation plans.
  • Conducts technical site assessments and trains staff on collection requirements.
  • Provides Quality Systems support by participating in deviation activities.
  • Monitors vendor performance and capacity after site launch.
  • Manages rollout of process changes.
  • Collects VOC and VOB feedback.
Key Responsibilities

Developing strong relationships with internal and external stakeholders is essential for success in this role. Key responsibilities include:

  • Coordinating onboarding activities for new Apheresis and Treatment Centres.
  • Preparing sites for collections and communicating on-boarding status.
  • Collaborating with Clinical and Commercial CAR-T teams to establish apheresis collection footprint.
  • Providing training and support to staff on collection requirements.
  • Participating in deviation activities to ensure quality systems are maintained.
Requirements

To be successful in this role, you will need to have experience in Apheresis Operations Management, QA Operations or GMP production, as well as a broad understanding of regulated environments and HTA regulations. Additional qualifications include:

  • Undergraduate degree in related science or nursing.
  • Fluency in English and Portuguese.
Benefits

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Other Requirements

This role requires excellent interpersonal and presentation skills, as well as the ability to prioritize work with a sense of urgency. Rapid problem-solving skills and a high attention to detail are also essential.

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