Manager, CAR-T Cell Collection Operations

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Procurement

Job Sub Function: Strategic Sourcing

Job Category: Professional

All Job Posting Locations: Raritan, New Jersey, United States of America, Remote (US)

Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Manager, CAR-T Cell Collection Operations to join our team in Raritan, NJ.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team! 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.

Key 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.

Qualifications: Education: • 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

Experience and Skills: Required: • 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

Preferred: • Hospital experience or understanding of drug development and regulatory submission requirements

• Experience with qu

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