Senior Cell Therapy Operations Specialist

This role will oversee the onboarding and ongoing performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. The successful candidate will serve as the technical operations single point of contact for these centres, located within a designated region.

The Cell Therapy Operations Manager will be responsible for developing and fostering relationships with Apheresis, Cell Lab, and Treatment Centre Staff for assigned regions. This includes 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.

The ideal candidate will possess experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant operational areas. They should have a strong understanding of regulated environments and familiarity with HTA regulations.

The successful candidate will work closely with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for assigned regions. They will also 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.

In addition, the Cell Therapy Operations Manager will be responsible for performing technical site assessments, training collection centre staff on collection requirements, and attending site audits as required. They will provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres.

The ideal candidate will possess excellent interpersonal and presentation skills, with the ability to communicate effectively across all levels within the organization and multiple cultures. They should have a strong attention to detail, with the ability to prioritize and complete work with a sense of urgency based on criticality.

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
• Perform technical site assessments and train collection centre staff on collection requirements
• Attend site audits as required and provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centres
• 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 and VOB feedback used for continuous operations improvement
• Represent the department on cross-functional project teams as requested

Required Skills and Qualifications:

• Experience in Apheresis Operations Management, QA Operations, GMP production, or other relevant operational areas
• Strong understanding of regulated environments and familiarity with HTA regulations
• Excellent interpersonal and presentation skills
• Ability to communicate effectively across all levels within the organization and multiple cultures
• Strong attention to detail with ability to prioritize and complete work with a sense of urgency based on criticality
• Medical, scientific, and clinical knowledge
• Knowledge of applicable regulations and standards

Benefits:

• Remote work opportunities available
• Opportunities for professional growth and development
• Competitive compensation package