Manager CAR-T Cell Collection Operations

Johnson & Johnson - Lincoln, NE

Full-time - Manager

Remote - Lincoln, NE

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 various stakeholders, managing supplier relationships, and leading technical operations related to cell collection and processing. The position requires collaboration with hospitals and third-party centers to maintain operational excellence and compliance with regulatory standards.

Responsibilities

• Manage and maintain commercial CAR-T apheresis and cryopreservation activities in support of 2500-3000 CAR-T patient commercial supply chain activities.
• Serve as primary point of contact for apheresis centers and local cryopreservation cell laboratories.
• Facilitate and conduct site qualification and training for collections and/or cryopreservation requirements.
• Activate site as approved supplier prior to First Patient In (FPI) date.
• Ensure timely receipt of recall communications from apheresis centers and evaluate impact to 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 solid understanding of information technology, logistic transport 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; focused degree in Nursing, Medical Laboratory Science or equivalent scientific or engineering field is preferred.
• Minimum 8 years of relevant work experience.
• Minimum 4 years of relevant hands-on experience with Immunology, Cell Biology, Cell Therapy or Apheresis.
• Strong communication and interpersonal skills, with the ability to work independently and in a cross-functional team environment.
• Ability to engage with hospital personnel to communicate specific and technical requirements for apheresis and cell cryopreservation.
• Proven experience with Good Tissue Practices (GTP) and current Good Manufacturing Practices (cGMP).
• Flexibility to adapt to changing situations and ambiguity, to prioritize tasks according to objectives, and provide problem resolution.

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
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay - up to 13 days per calendar year
• Floating Holidays - up to 40 hours per calendar year