Global Cell Collection and Cryopreservation Manager, EMEA

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About the job

CAR-T Cell Collection Manager EMEA

To be located in Europe/UK or working remotely from any EU/UK location.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.

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. This team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

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. The successful candidate is therefor able to appropriately balance the requirements at apheresis and cell processing sites as it relates to multiple in-flight programs/indications: early development, clinical trials, and commercial activities. The capability to effectively facilitate site certification activities including large, centralized cell processing labs is critical. This will include site education/ training for doctors, technicians and nurses as needed. Importantly, after site qualification, a professional ‘hospital as supplier’ relationship should be managed where near-real-time quality investigations around apheresis and/or cryopreservation are an important part of the role. Up-to-date knowledge of industry standards and regulatory requirements related to cellular therapies are critical.

Given the central role in the organization, colleagues that able to naturally foster strong partnerships with other groups such as clinical and commercial operations are most influential, e.g. in reducing our supply base and achieve cost reduction goals.

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, 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 FPI 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 evaluate impact to product quality
    
    
    

Qualifications

Qualifications:

• A master’s degree, preferably in medical biology, nursing, or a related discipline such as cell biology is required
• An advanced degree in a relevant scientific discipline is preferred (e.g. cell therapies, oncology, biopreservation)
• A minimum of 7 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
• Direct white blood cells cryopreservation laboratory experience or clinical apheresis experience is required
• 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
• 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
• Has demonstrated to be agile and able to make decisions independently; an innovative and strategic thinker with broad vision is required
• 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 other major European language such as Spanish, Italian, or French is required
• Travel may be required up to 20% of time
• Eligible to work in the European Union or UK

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