Tissue Operations Manager
1 semana atrás
At our organization, we partner with a clinical-stage biopharmaceutical company to develop cutting-edge, programmed T cell therapies for cancer treatment. Our partners use proprietary technologies to create targeted and highly active T cell therapies that can recognize cancer cells, break down their defenses and eliminate them.
This role is responsible for overseeing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. As the technical operations single point of contact, you will serve as a liaison between various teams and stakeholders.
Key Responsibilities:- Establish strong relationships with Apheresis, Cell Lab and Treatment Centre Staff
- Collaborate with Clinical and Commercial CAR-T teams to establish apheresis collection footprint
- Coordinate site onboarding activities and ensure sites are prepared to perform collections
- Communicate collection site on-boarding status and develop mitigation plans
- Perform technical site assessments and train staff on collection requirements
- Provide Quality Systems support and participate in deviation activities
- Work with internal teams to monitor vendor performance and capacity
- Manage rollout of process changes to assigned sites
- Collect VOC and VOB feedback for continuous improvement
Demonstrated skills and competencies include:
- Experience in Apheresis Operations Management, QA Operations or GMP production
- Breadth of experience in regulated environments and understanding of HTA
- Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs
- Ability to rapidly solve problems and deal with organizational complexity
- Medical, scientific and clinical knowledge
- Knowledge of applicable regulations and standards
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Brasil RBW Consulting Tempo inteiroRBW Consulting are partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to...
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Brasil RBW Consulting Tempo inteiroRBW Consulting are partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to...
