Lead Apheresis Operations Specialist

Há 5 dias


Porto Alegre, Rio Grande do Sul, Brasil beBeeOperations Tempo inteiro R$900.000 - R$1.200.000
Apheresis Operations Management Role

The role is accountable for overseeing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.

This position serves as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region and may require management of contract employees.

  • Develop relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
  • Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprint to support clinical trial site plans for assigned region.
  • Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within required timelines.
  • Communicate collection site on-boarding status to Clinical teams and develop mitigation plans for delayed timelines.
  • Perform technical site assessments and train collection center staff on collection requirements.
  • Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
  • Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
  • Manage rollout of process changes to assigned sites.
  • Collect VOC and VOB feedback for continuous operations improvement.
  • Collect and enter data into electronic data management systems.
  • Represent the department on cross-functional project teams.

Demonstrated skills and competencies:

  • Experience in regulated environments, including QA Operations, GMP production, and other relevant operational areas.
  • Breadth of experience in quality assurance, understanding of HTA regulations.
  • Experience working with critical raw material suppliers or contract manufacturing organizations.
  • Ability to work in a team-based environment.
  • Delivering process improvements in processes for qualification, training, and management of external cell procurement suppliers.
  • Undergraduate degree in related science or nursing.

We are seeking an experienced professional to fill this key role. The ideal candidate will have a strong background in Apheresis Operations Management, QA Operations, and GMP production, as well as excellent communication and leadership skills.


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