Tissue Operations Director
Há 4 dias
Operations Manager Job Summary:
The Operations Manager is accountable for overseeing the onboarding and ongoing performance of apheresis and treatment centers used for clinical chimeric antigen receptor (CAR) T-cell therapies.
- Develop relationships with apheresis, cell lab, and treatment center staff for assigned regions.
- Work with clinical and commercial CAR-T teams to establish apheresis collection footprints in support of trial site plans.
- Coordinate internal teams and collection sites to ensure successful completion of onboarding activities within required timelines.
- Communicate onboarding status to clinical teams and develop mitigation plans for delayed timelines.
- Perform technical site assessments, train staff on collection requirements, and attend audits as needed.
- Provide quality systems support by participating in deviation activities and impact/investigation assessments.
- Monitor and assess vendor performance and capacity after site launch.
- Manage process rollouts to assigned sites.
- Collect VOC feedback for continuous operations improvement.
- Enter data into electronic management systems.
- Represent the department on cross-functional project teams.
- Comply with applicable SOPs and regulations.
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