Manager CAR-T Cell Collection Operations

$80,000 - $146,000/Yr

Johnson & Johnson - Juneau, AK

Full-time - Manager

Remote - Juneau, AK

5,001-10,000 employees

Chemical Manufacturing

About the position

The Manager CAR-T Cell Collection Operations at Johnson & Johnson is responsible for overseeing the coordination and maintenance of apheresis and cryopreservation activities for CAR-T cell therapy products. This role involves managing relationships with hospitals and suppliers, ensuring quality and compliance in the collection and processing of cell therapy materials, and supporting the training and certification of collection sites. The position requires strong leadership and communication skills to effectively collaborate with cross-functional teams and ensure the successful delivery of CAR-T therapies to patients.

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).
• 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.
• 401(k) retirement plan and savings plan participation.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.