Senior Operations Specialist
Há 2 dias
RBW Consulting seeks a highly skilled Senior Operations Specialist to manage the onboarding and performance of Apheresis and Treatment Centres for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies.
About the RoleThis senior-level position requires expertise in contract employee management, technical operations, and relationship development with cross-functional teams.
The ideal candidate will possess exceptional problem-solving skills, organizational complexity management, and the ability to prioritize tasks with urgency based on criticality.
Key Responsibilities- Develop strong relationships with Apheresis, Cell Lab, and Treatment Centre Staff.
- Collaborate with Clinical and Commercial CAR-T teams to establish apheresis collection footprints.
- Coordinate internal team and collection site staff to ensure successful onboarding activities and timely site preparation.
- Communicate on-boarding status to Clinical teams and develop mitigation plans for delayed timelines.
- Perform technical site assessments, train collection centre staff, and attend site audits as required.
- Provide Quality Systems support by participating in deviation activities and impact/investigation assessments.
- Work with Quality Assurance and internal business partners to monitor vendor performance and capacity.
- Manage process changes rollout to assigned sites.
- Collect VOC and VOB feedback for continuous operations improvement.
- Apheresis Operations Management, QA Operations, GMP production, or relevant operational areas.
- Regulated environment experience, understanding of HTA (hospital or pharmaceutical/biopharmaceutical company).
- Apheresis, Cellular Therapy, or Stem Cell Transplant programs knowledge.
- Critical raw material suppliers or contract manufacturing organizations management.
- Team-based environment experience.
- Process improvements in qualification, training, and management of external cell procurement suppliers.
This role offers a unique opportunity to work in a rapidly evolving field, with a focus on delivering high-quality services and products. The ideal candidate will be motivated by the prospect of making a meaningful contribution to the success of our organization.
We offer a competitive compensation package, including benefits and opportunities for professional growth and development.
This is a remote-based position, with up to 75% regional travel required.
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