
Senior Tissue Operations Leader
Há 4 dias
About the Role:
We are seeking a highly skilled and experienced Manager to lead our Tissue Operations team. The successful candidate will be responsible for managing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.
This is a remotely based role that requires travel up to 75% of the time. You will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within your designated region, working closely 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.
Main Responsibilities:
- Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
- Work with Clinical and Commercial CAR-T teams to establish the 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 and execute mitigation plans for any delayed timelines.
- Perform technical site assessments and train collection center staff on collection requirements and attend site audits as required.
- 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.
Requirements:
- Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or other relevant operational areas.
- Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
- Strong organizational skills with ability to multi-task several tasks in parallel.
- Ability to rapidly solve problems and deal with organizational complexity.
- Excellent interpersonal and presentation skills to communicate effectively across all levels and cultures.
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