Cell Therapy Operations Manager
3 semanas atrás
Overview
The therapeutic pipeline includes product candidates in development for the treatment of haematological malignancies and solid tumours.
Responsibilities- Develop and foster relationships with apheresis staff.
- Work with clinical and commercial teams to establish collection footprints.
- Coordinate onboarding activities at sites to ensure timely performance.
- Communicate site on-boarding status and develop mitigation plans for delayed timelines.
- Perform technical assessments and train staff on collection requirements.
- Provide quality support by participating in deviation activities and impact assessments.
- Monitor vendor performance and capacity after site launch.
- Manage rollout of process changes and collect VOC (voice of customer) feedback.
- Represent the department on cross-functional project teams as requested.
- Comply with applicable SOPs and regulations.
- Experience in apheresis operations management, QA operations or GMP production.
- Breadth of experience in regulated environments, understanding of HTA.
- Working knowledge of cellular therapy programs.
- Qualifications include an undergraduate degree in related science or nursing and fluency in English.
Competitive Benefits: Professional growth opportunities, career advancement, working with experienced professionals, supportive team environment.
About the CompanyA clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer.
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