Manager CAR-T Cell Collection Operations

Johnson & Johnson - Trenton, NJ

Full-time - Manager

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Manager CAR-T Cell Collection Operations at Johnson & Johnson is responsible for overseeing the coordination and maintenance of a virtual supplier network for apheresis and cryopreservation of starting materials for CAR-T products. This role involves collaboration with various teams to ensure high-quality cell therapy products and effective supplier relationships, while also managing operational activities related to patient supply chains.

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.
• Complete quality issues management within 24-48 hours post apheresis.
• Complete risk and change management.
• Develop understanding of IT, logistics, and regulatory requirements affecting collection and cryopreservation of apheresis starting material.
• 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.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.