Manager, CAR-T Cell Collection Operations
About The Position
This role is for a Manager, CAR-T Cell Collection Operations at Johnson & Johnson, located in Raritan, NJ, with potential for remote work. The position is within the Innovative Medicine sector, specifically supporting a collaboration between Janssen Biotech, Inc. and Legend Biotech USA Inc. to develop, manufacture, and commercialize a CAR-T cell therapy. The Manager will coordinate and maintain a virtual supplier network of apheresis and cryopreservation starting material for clinical and commercial CAR-T products, primarily in the United States. They will lead the technical relationship with Operating Company-level cell therapy teams, collaborate with commercial CAR-T teams, facilitate cell collection site certification, support training, and manage quality investigations. The role involves collaborating with "hospitals as suppliers," completing technical analyses, and identifying opportunities for performance improvement. The Manager may also implement programs for supply base reduction and cost reduction, and lead supplier capabilities including capacity planning and inventory management. This role provides global and multi-site support.
Requirements
- Minimum of a Bachelor’s/University or equivalent degree required; focused degree in Nursing, Medical Laboratory Science, or equivalent scientific or engineering field is preferred
- Minimum 6 years of relevant work experience
- Hands-on experience with Immunology, Cell Biology, Cell Therapy, Apheresis, and/or Cryopreservation
- Strong communication and interpersonal skills, with the ability to work independently and in a cross-functional team environment, to effectively support supplier relationship with cell 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)
- Flexibility to adapt to changing situations and ambiguity, to prioritize tasks according to objectives, and provide problem resolution
- Strong written and verbal communication skills
Nice To Haves
- Hospital experience or understanding of drug development and regulatory submission requirements
- Experience with quality issues management (e.g., investigations, deviations, CAPAs, etc.)
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 POC for apheresis center, local cryopreservation cell laboratories, as well as, 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.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
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What This Job Offers
Job Type
Full-time
Career Level
Manager
