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This role oversees the onboarding and performance of apheresis and treatment centers used for CAR-T cell therapies.
The job holder will be the technical operations single point of contact for apheresis and treatment centers within a designated region, managing contract employees as needed.
Key Responsibilities- Apheresis Operations Management: Develop relationships with apheresis, cell lab, and treatment center staff in assigned regions.
- Clinical Trial Support: Collaborate with clinical and commercial CAR-T teams to establish the apheresis collection footprint for assigned regions.
- Collection Site Onboarding: Coordinate with internal teams and collection site staff to ensure successful completion of onboarding activities and sites are prepared for collections within required timelines.
- Mitigation Planning: Communicate collection site on-boarding status to clinical teams and develop mitigation plans for delayed timelines.
- Tech Site Assessments: Perform technical site assessments and train collection center staff on collection requirements, attending site audits as needed.
- Quality Systems Support: Participate in deviation activities and impact/investigation assessments for cell collection centers.
- Vendor Performance Monitoring: Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
- Process Improvement: Manage rollout of process changes to assigned sites, collect VOC (voice of customer) and VOB (voice of business) feedback for continuous operations improvement.
- Essential:
- Apheresis operations management experience.
- QA operations or GMP production experience.
- Regulated environment experience, including HTA knowledge.
- Team-based environment experience.
- Experience delivering process improvements, ideally in qualification, training, and management of external cell procurement suppliers.
- Contract management experience.
- Preferred:
- Apheresis, cellular therapy, or stem cell transplant program experience.
- Critical raw material supplier or contract manufacturing organization experience.
- Advanced degree in related science or nursing.
- Prior customer-facing role in the pharmaceutical/biotech industry.
- Rapid Problem Solving: Ability to rapidly solve problems and deal with organizational complexity.
- Time-Sensitive Tasks: Ability to prioritize and complete work with a sense of urgency based on criticality.
- Medical Knowledge: Medical, scientific, and clinical knowledge.
- Regulatory Compliance: Knowledge of applicable regulations and standards.
