Manager Car-t Cell Collection Operations

3 months ago


Toronto, Canada Johnson & Johnson Full time

Johnson & Johnson is currently seeking a Manager CAR-T Cell Collection Operations to join our TEAM

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

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 Manager 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 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 or equivalent University Degree required; focused degree in Nursing, Medical Laboratory Science or equivalent scientific or engineering field is preferred.

Experience and Skills:
Required:

- Minimum 8 years of relevant work experience
- Minimum 4 years of relevant hands-on experience with Immunology, Cell Biology, Cell 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 10-15 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

Other:

- Requires up to 25% domestic and international travel
- Fluency in English is required; Canadian French is preferred
- This position requires ability and flexibility to work on weekends/off hours for patient support.

The anticipated base pay range for this position is 99000 to 170200.

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)).
- Employees are eligible for the followi



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