Manager Global Cell Collection EMEA

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is currently seeking aCAR-T Cell Collection Manager EMEA to join our TEAM preferably located in Beerse Belgium. The role however offers hybrid work regime allowing to post this role in other EMEA locations as well.

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 the Innovative Medicine organization within Belgium and across the EMEA region we are committed to advancing cuttingedge cell therapy solutions that transform patients lives. Our CART initiatives bring together deep scientific expertise strong operational capabilities and a collaborative ecosystem of partners to accelerate the development manufacturing and delivery of nextgeneration immunotherapies.

Are you motivated to contribute to lifechanging therapies by ensuring excellence in the quality and consistency of our cell therapy starting materials Join us and become part of the #CART team driving meaningful impact for patients.

Reporting to the Senior Manager the CART Cell Collection Manager is responsible for coordinating and sustaining a virtual supplier network of apheresis and cryopreservation sites supporting clinical and commercial CART products across the EMEA region. As a subject matter expert this role leads technical engagement with countrylevel cell therapy teams and partners closely with commercial CART functions. The Manager oversees site readiness and certification activities for apheresis and cell laboratories supports and delivers training for healthcare professionals and facilitates timely quality investigations related to apheresis or cryopreservation processes when needed.

The role requires effective collaboration with hospitals functioning as key suppliers including conducting technical assessments to ensure highquality and reliable services. The Manager fosters strong working relationships with operational partners drives continuous improvement and may contribute to optimizing the supplier base and achieving costefficiency goals. Responsibilities also include oversight of supplier capabilities such as capacity planning and inventory management with support extending across multiple countries and operational environments.

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 cryopreservation centers
• Serve as apheresis and cryopreservationSubject 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.
• Work on strategic projects focused on standardizationprocess improvement and ameliorating the customer experience
• Network with different internal and external stakeholders collaborate across different geographic regions

Qualifications:

Education:

• Minimum of a Bachelors/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 internal cell therapy coordinators and when needed 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 to communicate effectively and professionally; proficiency inFrench and/or Italian is preferred
• Requires up to 20%travel
• May requireability 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 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

Additional information can be found through the link below. For additional general information on Company benefits please go to: Skills:

Preferred Skills: