CAR T Cell Collection Lead

Johnson & Johnson Innovation; Antwerpen; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson Innovation seeks a CAR-T Cell Collection Lead to develop and implement strategies for efficient, quality-driven cell collection aligning with regulatory standards and organizational goals. You will coordinate a virtual supplier network for apheresis and cryopreservation starting materials for clinical and commercial CAR-T products, partnering with hospital teams across the EMEA region.

The role requires strong PM skills, cGMP knowledge, and the ability to work in a

Qualifications

• Master or bachelor degree; focused degree in Nursing, Medical Laboratory Science, Chemistry or equivalent.
• Advanced degree or experience in apheresis 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 with JACIE knowledge.
• Direct cell therapy laboratory experience or clinical apheresis experience is preferred.
• Ability to work in multinational teams and a matrixed environment.
• PM skills and cross-functional interfacing with clinical personnel is required.
• Travel up to 20% may be required.

Responsabilités

• 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 the 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.

Connaissances

Project Management

Cross-functional collaboration

Regulatory knowledge

cGMP

English proficiency

Multinational teamwork

Supplier management

Apheresis experience

Formation

Bachelor's or Master degree

Preferred in Nursing/Medical Lab/Chemistry/Engineering

Description du poste

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.

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

Required Skills:

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

The anticipated base pay range for this position is:

Benefits:

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 location’s 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.