Manager, CAR-T Cell Collection Operations

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 Brazil. 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 analysesto 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 up to 30 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

Preferred:

• Hospital experience or understanding of drug development and regulatory submission requirements
• Experience with quality issues management (e.g., investigations, deviations, CAPAs, etc.)

Other:

• Requires proficiency in English and Portuguese (written and verbal) to communicate effectively and professionally; proficiency in Spanish is highly preferred
• Requires up to 25% domestic and international travel (e.g., Brazil, Argentina, and United States)
• Requires ability and flexibility to work on weekends/off hours for patient support, including the ability to accommodate different global time zones (i.e., LATAM, NA, and EMEA)

Why Johnson & Johnson

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

The anticipated base pay range for this position is $100,000 USD to $172,500 USD.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Employees are eligible for the following time off benefits:

• 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

Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.

This job posting is anticipated to close on February 10, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.