CAR-T Cell Collections, Lead

Johnson & Johnson • Raritan, NJ

5d • $94,000 - $151,800

About The Position

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. 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.

The CAR-T Cell Collection Operations Lead coordinates, and maintains virtual supplier network of apheresis and cryopreservation starting material for clinical and commercial CAR-T products. 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 Lead is responsible for effectively collaborating with "hospitals as suppliers" and completes appropriate technical analysis to assure quality services. They will maintain positive collaborations with other operation groups, identifying options to improve performance. The Lead may implement programs to reduce supply base and achieve cost reduction goals. They will lead supplier capabilities including capacity planning and inventory management.

Requirements

• Minimum of a Bachelor’s of Science or equivalent University Degree required; focused degree in Nursing, Medical Laboratory Science or equivalent scientific or engineering field is preferred.
• Minimum 4 years of relevant work experience
• Minimum 2 years of relevant hands-on experience with Immunology, Cell Biology, Cellular Therapy, or Apheresis
• Strong communication and interpersonal skills, with the ability to work independently and in a cross-functional team environment, to effectively support supplier relationship with 20-30 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

Nice To Haves

• Hospital experience or understanding of drug development and regulatory submission requirements
• Experience with quality issues management
• Project management experience

Responsibilities

• Lead and maintain commercial CAR-T apheresis and cryopreservation activities in support of 400-500 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level