Manager CAR-T Cell Collection Operations

Johnson & Johnson - Madison, WI

Full-time - Manager

Remote - Madison, WI

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 before 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.
• Conduct risk and change management activities.
• 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 regarding apheresis and cryopreservation requirements.
• Proven experience with Good Tissue Practices (GTP) and current Good Manufacturing Practices (cGMP).
• Understanding of drug development and regulatory submission requirements.
• 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 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)