Apheresis and Tissue Operations Specialist
Há 3 dias
Apheresis/Tissue Operations Manager is a part-time role that requires remote work with occasional travel to designated regions.
The ideal candidate will be fluent in English and Portuguese and have experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant operational areas.
Key Responsibilities:- Develop and foster relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned regions.
- Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for assigned regions.
- 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.
- Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.
- Collect and enter data into electronic data management systems.
- Represent the department on cross-functional project teams, as requested.
- Comply with applicable SOP's and regulations.
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