Manager CAR-T Cell Collection Operations

Johnson & Johnson - Columbia, SC

Full-time - Manager

Remote - Columbia, SC

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, including hospitals and third-party centers, to maintain operational efficiency and compliance with regulatory standards. The manager will also lead training initiatives, manage supplier relationships, and address quality issues in a timely manner, contributing to the overall success of the CAR-T supply chain.

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 center, local cryopreservation cell laboratories, and contracted third-party apheresis/cryopreservation centers within assigned regions.
• Serve as apheresis Subject Matter Authority for internal and external teams.
• 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, to effectively support supplier relationship with 10-15 collection sites.
• 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).
• Hospital experience or understanding of drug development and regulatory submission requirements.
• 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, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year.