CAR-T Cell Collection Lead: Ops & Compliance

Johnson & Johnson Innovative Medicine; Gierle; On-site; EUR 90,000 - 140,000; Full time

Job summary

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%.

Responsibilities

• 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.

Skills

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

Education

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

Job description

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