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4 semanas atrás
We are seeking a seasoned professional to oversee the management of Apheresis and Treatment Centres for CAR T-cell Therapies.
This role will involve developing strong relationships with Apheresis, Cell Lab, and Treatment Centre Staff, as well as working closely with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint.
Responsibilities:- Manage Apheresis and Treatment Centres for CAR T-cell Therapies
- Develop strong relationships with Apheresis, Cell Lab, and Treatment Centre Staff
- Work with Clinical and Commercial CAR-T teams to establish apheresis collection footprint
- Coordinate onboarding activities at collection sites
- Communicate onboarding status to Clinical teams and develop mitigation plans for delayed timelines
- Perform technical site assessments and train collection centre staff
- Provide Quality Systems support by participating in deviation activities
- Monitor vendor performance and capacity after site launch
- Manage rollout of process changes to assigned sites
- Essential: Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant areas
- Experience working in regulated environments and understanding of HTA
- Proven ability to work in a team-based environment
- Experience in delivering process improvements
- Prior customer-facing role in pharmaceutical/biotech industry
- Bachelor's degree in related science or nursing
- Advanced degree in related science or nursing (optional)
- Fluency in English and Portuguese
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