Global Cell Collection and Cryopreservation Manager, EMEA in High Wycombe

Role Summary

Cancer immunology has rapidly progressed to one of the most promising forms of new treatments in which not the cancer, but the immune system is treated. This innovative and promising form of autologous cellular therapy provides real hope to patients in need. The CAR‑T organization within Janssen is working on a full pipeline with our most advanced candidate for the treatment of multiple myeloma being on the verge of commercialization. The Global Cell Collection (GCC) team works passionately to build and maintain a supplier network of apheresis starting materials as well as cryopreservation centers. We are a fast‑developing group and forward looking, working on improving cost of goods, being customer focused and support the need for speed. The key role of Manager Cell Collection EMEA acts as the primary commercial CAR‑T Janssen Supply Chain Subject Matter Expert who leads technical relationship with Operating Company level Cell Therapy teams.

Responsibilities

• Identifies, 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 around 20 sites, shaping the EU network.
• Oversees tech transfers of the cryopreservation process to 10 local hospitals and 2 central cell processing facilities.
• Acts as primary point of contact and maintains relations with 20 commercial suppliers of apheresis and/or cryopreservation services.
• Refines and executes site selection, qualification and onboarding activities.
• Develops working knowledge of information technology, logistics and medical know‑how.
• Executes issues management, risk management, change management and recalls.
• Designs and maintains metrics to monitor site performance.
• Builds and shapes infrastructure and capabilities to regionally support commercial activities (internal and external).
• Ensures site qualification/certification completed and documented prior to First Product Introduction in a selection of European countries.
• Conducts and oversees change management related to process and equipment changes that could impact Janssen product.
• Ensures timely receipt of recall communications from apheresis centers and evaluates impact on product quality.

Qualifications

• Master’s degree, preferably in medical biology, nursing, or a related discipline such as cell biology is required.
• Advanced degree in a relevant scientific discipline is preferred (e.g., cell therapies, oncology, biopreservation).
• Minimum of 7 years of experience in a pharma, hospital or blood bank environment.
• In‑depth knowledge of cGMP and the EU Tissue and Cell Directives is required.
• Full proficiency in the European Regulations and Directives, ideally supplemented with solid knowledge of the JACIE standards.
• Direct white blood cell cryopreservation laboratory experience or clinical apheresis experience is required.
• Ability to work effectively in multinational teams and enjoy a multicultural environment.
• Project management skills and the ability to interface cross‑functionally with clinical personnel is required.
• Understanding of cellular therapy development and submission requirements is preferred.
• Manufacturing and logistics understanding/experience is preferred.
• Experience working independently and in a matrixed team environment is required.
• Demonstrated agility, independent decision‑making, innovative and strategic thinking with broad vision.
• Flexibility to adapt to changing situations, prioritize tasks according to objectives and provide problem resolution.
• Fluently English and proficiency in reading, writing and speaking at least one other major European language such as Spanish, Italian or French.

Travel

Travel may be required up to 20% of the time.

Legal

Eligible to work in the European Union or UK.

Required & Preferred Skills

• Business Data Analysis
• Business Savvy
• Category Management Strategy
• Consulting
• Cost Management
• Due Diligence
• Market Savvy
• Negotiation
• Problem Solving
• Process Improvements
• RFx Management
• Risk Assessment
• Risk Management
• Spend Analysis
• Strategic Sourcing
• Supplier Collaboration
• Technical Credibility
• Vendor Management
• Vendor Selection