Senior Operations Manager
4 semanas atrás
The ideal candidate will be responsible for overseeing the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.
About this Role:- This role involves developing and maintaining relationships with Apheresis, Cell Lab and Treatment Centre Staff to ensure seamless operations.
- The Senior Operations Manager will work closely with Clinical and Commercial CAR-T teams to establish apheresis collection footprints in support of clinical trial site plans.
- Critical responsibilities include coordinating internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed within required timelines.
- The selected candidate will communicate collection site onboarding status to Clinical teams and develop mitigation plans for any delayed timelines.
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 apheresis collection footprints in support of clinical trial site plans.
- Coordinate internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed within required timelines.
- Communicate collection site onboarding status to Clinical teams and develop mitigation plans for any delayed timelines.
- Perform technical site assessments and train collection center staff on collection requirements.
- Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
- Manage rollout of process changes to assigned sites.
- Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.
- Represent the department on cross-functional project teams as requested.
- Breadth of experience in regulated (GxP) environments, understanding of HTA (either hospital or pharmaceutical/biopharmaceutical company).
- Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs preferred.
- Has successfully worked in a team-based environment.
- Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement suppliers.
- Undergraduate degree in related science or nursing required.
- Fluency in English and Portuguese is essential.
What We Offer:
- Rapidly solve problems and deal with organizational complexity.
- Prioritize and complete work with sense of urgency based on criticality.
- Medical, scientific and clinical knowledge.
- Knowledge of applicable regulations and standards.
- High attention to detail skills.
- High organization skills with ability to multi-task several tasks in parallel.
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