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 managing relationships with hospitals and suppliers, facilitating training and site qualifications, and ensuring compliance with regulatory standards. The position supports a global supply chain for CAR-T therapies and requires collaboration with various internal and external teams to maintain operational excellence.

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 within assigned regions.
• 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 and complete risk and change management.
• Develop understanding of IT, logistics, and regulatory requirements affecting collection and cryopreservation of apheresis.
• Maintain metrics to manage site performance.

Requirements

• Minimum of a Bachelor's or equivalent University Degree required, preferably in Nursing, Medical Laboratory Science, or a related 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).
• Flexibility to adapt to changing situations and prioritize tasks.

Nice-to-haves

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

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• 401(k) retirement plan and savings plan participation.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; up to 56 hours for employees in Washington.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.