Manager CAR-T Cell Collection Operations

Johnson & Johnson - Boston, MA

Full-time - Manager

Remote - Boston, MA

Chemical Manufacturing

About the position

The Manager CAR-T Cell Collection Operations at Johnson & Johnson is responsible for overseeing the commercial CAR-T apheresis and cryopreservation activities, ensuring high-quality cell therapy products for patients. This role involves coordinating with hospitals and suppliers, managing technical relationships, and facilitating training and site qualifications. The position requires strong collaboration with various teams to improve performance and maintain quality standards in the supply chain for CAR-T therapies.

Responsibilities

• Manage and maintain commercial CAR-T apheresis and cryopreservation activities for 2500-3000 CAR-T patient supply chain activities.
• Serve as primary point of contact for apheresis centers and cryopreservation laboratories.
• Act as apheresis Subject Matter Authority for internal and external teams.
• Facilitate site qualification and training for collections and cryopreservation requirements.
• Activate sites as approved suppliers prior to First Patient In (FPI) date.
• Ensure timely receipt of recall communications from apheresis centers and evaluate impact on product quality.
• Ensure timely release of quality fresh/cryopreserved apheresis starting material.
• Manage quality issues within 24-48 hours post apheresis.
• Complete risk and change management processes.
• Develop understanding of IT, logistics, and regulatory requirements affecting collection and cryopreservation.
• Maintain metrics to manage site performance.

Requirements

• Minimum of a Bachelor's or equivalent University Degree required; preferred in Nursing, Medical Laboratory Science, or equivalent scientific/engineering field.
• Minimum 8 years of relevant work experience.
• Minimum 4 years of hands-on experience with Immunology, Cell Biology, Cell Therapy, or Apheresis.
• Strong communication and interpersonal skills to work independently and in cross-functional teams.
• Ability to engage with hospital personnel to communicate technical requirements for apheresis and cryopreservation.
• Proven experience with Good Tissue Practices (GTP) and current Good Manufacturing Practices (cGMP).
• Understanding of drug development and regulatory submission requirements.

Nice-to-haves

• Hospital experience or understanding of drug development and regulatory submission requirements.
• Experience with quality issues management.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation time (up to 120 hours per year)
• Sick time (up to 40 hours per year)
• Holiday pay (up to 13 days per year)
• Floating holidays
• Work, Personal and Family Time (up to 40 hours per year)