CAR-T Apheresis & Cryopreservation 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

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