Cell Therapy Operations Manager

Há 5 dias

Manaus, Amazonas, Brasil beBeeOperational Tempo inteiro
Job Description

This is a key role in the development of next-generation, programmed T cell therapies for cancer treatment. We are seeking a seasoned professional to oversee onboarding and ongoing performance of Apheresis and Treatment Centres for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

The successful candidate will serve as the technical operations single point of contact for Apheresis and Treatment Centres within designated regions, collaborating with internal teams to ensure successful onboarding and timely collections.

Responsibilities
  • Develop strong relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned regions.
  • Collaborate with clinical and commercial teams to establish apheresis collection footprints supporting clinical trial site plans.
  • Coordinate internal team and collection site staff activities to achieve seamless onboarding and efficient collections.
  • Communicate collection site on-boarding status to clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments and train collection centre staff on collection requirements.
  • Provide quality systems support by participating in deviation activities and impact/investigation assessments.
  • Work with Quality Assurance to monitor vendor performance and capacity after site launch.
  • Manage rollout of process changes to assigned sites.
Key Skills and Qualifications
  • Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant operational areas.
  • Breadth of experience in regulated environments and understanding of HTA.
  • Experience working in Apheresis, Cellular Therapy, or Stem Cell Transplant programs.
  • Fluency in English and Portuguese.
Benefits

This is a remotely based position serving designated regions. Regional travel up to 75% of time may be required.

About This Role

This is a critical role that requires a unique blend of technical expertise and interpersonal skills. The ideal candidate will possess a deep understanding of Apheresis and cellular therapy operations, as well as excellent communication and project management skills.

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