Manager CAR-T Cell Collection Operations

Johnson & Johnson - Cheyenne, WY

Full-time - Manager

Remote - Cheyenne, WY

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 management of commercial CAR-T supply chain activities. The position requires strong leadership and communication skills to facilitate site qualifications, manage supplier relationships, and address quality issues in a timely manner.

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 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