Manager CAR-T Cell Collection Operations

Johnson & Johnson - Denver, CO

Full-time - Manager

Remote - Denver, CO

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, manage supplier relationships, and facilitate training and certification activities. The position requires strong communication skills and the ability to adapt to changing situations while ensuring compliance with regulatory standards.

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 activities.
• Develop understanding of IT, logistics, and regulatory requirements affecting collection and cryopreservation of apheresis materials.
• 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.
• 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)