Manager, CAR-T Cell Collection Operations
About The Position
We are searching for the best talent for a Manager, CAR-T Cell Collection Operations to join our team in Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. Supported by their direct Senior Manager, the CAR-T Cell Collection Operations Manager coordinates and maintains virtual supplier network of apheresis and cryopreservation starting material for clinical and commercial CAR-T products primarily based in United States. With subject matter expertise, they lead the technical relationship with Operating Company-level cell therapy teams and closely collaborate with commercial CAR-T teams. They will facilitate cell collection site certification activities related to apheresis and cell lab, support/provide training for technicians/nurses as needed, and facilitate near-real-time apheresis and/or cryopreservation quality investigation when required. The Manager is responsible for effectively collaborating with "hospitals as suppliers" and completes appropriate technical analyses to ensure quality services. They will maintain positive collaborations with other operation groups, identifying options to improve performance. The Manager may implement programs to reduce supply base and achieve cost reduction goals. They will 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
