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Job Description:

The CAR-T Cell Collection Operations Lead is responsible for developing and implementing efficient, quality-driven cell collection processes that meet regulatory standards and align with organizational goals. The successful candidate will collaborate with cross-functional teams and external partners to optimize workflows and maintain a high level of operational excellence in cell collection. This role involves coordinating and maintaining a virtual supplier network for apheresis and cryopreservation starting materials for clinical and commercial CAR-T products. Leveraging subject matter expertise, the Lead will lead technical relationships with Operating Company-level cell therapy teams and closely partner with commercial CAR-T teams. The Lead will facilitate cell collection site certification activities, provide training as needed, and manage near-real-time quality investigations related to apheresis and cryopreservation. Additionally, the Lead will effectively collaborate with hospitals as suppliers, conducting technical analyses to ensure quality services, and identifying opportunities for performance improvement.

Job responsibilities

• Develops and implements commercial CAR-T apheresis and cryopreservation activities
• Facilitates and conducts qualification and training for hospitals throughout EMEA region
• Oversees tech transfers of the cryopreservation process to local hospitals and central cell processing facilities
• Acts as primary point of contact and maintains relations with commercial suppliers of apheresis and/or cryopreservation services
• Executes site qualification and onboarding activities
• Develops working knowledge of Information Technology, Logistics and medical know-how
• Executes issues management, risk management, change management
• Maintains metrics to monitor site performance
• Builds and shapes infrastructure and capabilities to regionally support commercial activities (internal and external)
• Maintain compliance with all company policies and procedures.

Skills/experience

• A master or bachelor degree; focused degree in Nursing, Medical Laboratory Science or equivalent scientific or engineering field is preferred.
• An advanced degree or experience in a relevant discipline, such as apheresis, is preferred
• A minimum of 4 years of experience in a pharma, hospital or blood bank environment is required
• In depth knowledge of cGMP and the EU Tissue and Cell Directives is required
• Fully proficient in the European Regulations and Directives, ideally supplemented with solid knowledge of the JACIE standards
• Direct white blood cells laboratory experience or clinical apheresis experience is preferred
• Ability to effectively work in multinational teams and enjoys a multicultural environment
• Project Management skills and the ability to interface cross-functionally with clinical personnel is required
• Understanding of cellular therapy development and submission requirements is preferred
• Manufacturing and logistics understanding/experience is preferred
• Experience working independently and in a matrixed team environment is required
• Has demonstrated to be agile and able to make decisions independently
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required
• In addition to fluently English, proficient in reading, writing and speaking at least one of the following major European languages is preferred: Italian, French or German
• Travel may be required up to 20% of time