CAR T Cell Collection Lead

Johnson & Johnson Innovative Medicine; Gierle; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a CAR-T Cell Collection Lead to develop and implement strategies ensuring efficient, quality-driven cell collection that meets regulatory standards and aligns with organizational goals. You will coordinate with cross-functional teams and external partners to optimize workflows for clinical and commercial CAR-T products.

The role includes maintaining a virtual supplier network for apheresis and cryopreservation materials, leading hospital site

Qualifications

• Minimum 4 years in pharma, hospital or blood bank environment.
• In-depth knowledge of cGMP and EU Tissue and Cell Directives.
• Proficiency in European regulations and JACIE standards for CAR-T supply chain.
• Direct cell therapy laboratory or clinical apheresis experience preferred.
• Ability to work in multinational, matrixed teams and interface with clinical personnel.
• Fluency in English; additional European language (Italian, French or German) preferred.
• Willingness to travel up to 20%.

Responsabilités

• Develops and implements commercial CAR-T apheresis and cryopreservation activities for the regional Center of Excellence.
• Facilitates qualification and training for hospitals across the EMEA region.
• Oversees tech transfers of cryopreservation processes to local hospitals and central facilities.
• Acts as primary contact and maintains relations with commercial apheresis/cryopreservation suppliers.
• Executes site qualification and onboarding activities.
• Gains knowledge of information technology, logistics and medical know-how.
• Manages issues, risk, and change processes.
• Maintains metrics to monitor site performance.
• Builds infrastructure to regionally support commercial activities.
• Maintains compliance with company policies and procedures.

Connaissances

CAR-T cell therapy

Cross-functional leadership

Project management

Regulatory compliance

cGMP knowledge

European regulations

JACIE standards

Independent decision making

Travel up to 20%

Multinational teamwork

Formation

Master's or Bachelor's degree in Nursing, Medical Laboratory Science, Chemistry or equivalent

Advanced degree in a relevant discipline preferred

Experience in pharma/hospital environment

Description du poste

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

Project/Program Management Group

Job Sub Function

Technology Program/Portfolio Management

Job Category

Professional

All Job Posting Locations

Beerse, Antwerp, Belgium, Issy-les-Moulineaux, France, Latina, Italy, Leiden, South Holland, Netherlands

Job Description

The CAR-T Cell Collection Lead is responsible for developing and implementing strategies aimed at ensuring efficient, quality-driven cell collection processes that meet regulatory standards and align with organizational goals. The successful candidate will collaborate with cross-functional teams and external partners to optimize workflows and maintain a high level of operational excellence in cell collection. This role involves coordinating and maintaining a virtual supplier network for apheresis and cryopreservation starting materials for clinical and commercial CAR-T products. Leveraging subject matter expertise, the Lead will lead technical relationships with Operating Company-level cell therapy teams and closely partner with commercial CAR-T teams. The Lead will facilitate cell collection site certification activities, provide training as needed, and manage near-real-time quality investigations related to apheresis and cryopreservation. Additionally, the Lead will effectively collaborate with hospitals as suppliers, conducting technical analyses to ensure quality services, and identifying opportunities for performance improvement.

Job responsibilities

• Develops and implements commercial CAR-T apheresis and cryopreservation activities in support of the regional Center of Excellence
• Facilitates and conducts qualification and training for hospitals throughout EMEA region
• Oversees tech transfers of the cryopreservation process to local hospitals and central cell processing facilities
• Acts as primary point of contact and maintains relations with commercial suppliers of apheresis and/or cryopreservation services
• Executes site qualification and onboarding activities
• Develops working knowledge of Information Technology, Logistics and medical know-how
• Executes issues management, risk management, change management
• Maintains metrics to monitor site performance
• Builds and shapes infrastructure and capabilities to regionally support commercial activities (internal and external)
• Maintain compliance with all company policies and procedures.

Skills/experience

• A master or bachelor degree; focused degree in Nursing, Medical Laboratory Science, Chemistry or equivalent scientific or engineering field is preferred.
• An advanced degree or experience in a relevant discipline, such as apheresis, is preferred
• A minimum of 4 years of experience in a pharma, hospital or blood bank environment is required
• In depth knowledge of cGMP and the EU Tissue and Cell Directives is required
• Fully proficient in the European Regulations and Directives, ideally supplemented with solid knowledge of the JACIE standards and quality standards for the CAR-T supply chain
• Direct cell therapy laboratory experience or clinical apheresis experience is preferred
• Ability to effectively work in multinational teams and enjoys a multicultural environment
• Project Management skills and the ability to interface cross-functionally with clinical personnel is required
• Experience working independently and in a matrixed team environment is required
• Has demonstrated to be agile and able to make decisions independently
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required
• In addition to fluently English, proficient in reading, writing and speaking at least one of the following major European languages is preferred: Italian, French or German
• Travel may be required up to 20% of time

Preferred Skills

Business Behavior, Coaching, Collaboration, Communication, Consulting, Cross-Functional Collaboration, Customer Alignment, Data Analysis, Data Visualization, Information Technology Strategies, Problem Solving, Process Improvements, Product Portfolio Management, Project Management Methodology (PMM), Project Management Office (PMO), Risk Assessments, Strategic Thinking, Technology Quotient

Benefits

The anticipated base pay range for this position is:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some locations eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.