Tissue Operations Manager

Há 3 dias

Brasil beBeeOperations Tempo inteiro

This role serves as the technical operations single point of contact for Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

The Senior Manager will be responsible for managing onboarding and ongoing performance of Apheresis and Treatment Centres, working with internal teams and collection site staff to ensure successful completion of all collection site onboarding activities.

Key responsibilities include:

  • Developing and fostering relationships with Apheresis, Cell Lab and Treatment Centre Staff
  • Coordinating with Clinical and Commercial CAR-T teams to establish apheresis collection footprint to support clinical trial site plans
  • Communicating collection site on-boarding status to Clinical teams and developing mitigation plans for any delayed timelines
  • Performing technical site assessments and training collection center staff on collection requirements
  • Providing Quality Systems support by participating in deviation activities and impact/investigation assessments
  • Monitoring and assessing vendor performance and capacity after site launch
  • Managing rollout of process changes to assigned sites
  • Collecting VOC (voice of customer) and VOB (voice of business) feedback for continuous operations improvement

This role requires experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas. The ideal candidate will have strong communication and interpersonal skills, with the ability to work effectively in a team-based environment.

The following qualifications are required:

  • Undergraduate degree in related science or nursing
  • Fluency in English

A strong understanding of applicable regulations and standards is also essential for this role.

Please submit your application if you meet the qualifications and have the necessary experience.

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