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 https://www.jnj.com

ABOUT INNOVATIVE MEDICINE

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-020400
Belgium - Requisition Number: R-018679
Johnson & Johnson is currently seeking a Cell Therapy Liaison to be located in High Wycombe, UK, or Beerse, Belgium.
The Clinical Cell Therapy Liaison group is a global team within J&J Innovative Medicine responsible to provide cell therapy expertise in support of our clinical trials network for cell collection, cell processing laboratories, cryopreservation sites and clinical patient journey support.
The Cell Therapy Liaison (CTL) is a member of the Cell Therapy Platform team and serves as a cross-functional expert within J&J IM to manage highly complex and novel technical aspects and logistics of treatment with human cells, tissues, and cellular and tissue-based products (HCT/Ps). This role provides expertise in establishing and maintaining processes including donor requirements, cell collection, cryopreservation, product handling, and storage for HCT/Ps. The CTL provides technical and operational support to clinical sites participating in J&J IM global cell therapy trials. The CTL also plays a lead role in resolving issues impacting the clinical sites and internal operational teams.
The CTL is involved in the selection, evaluation, and initiation of hospitals that collect and process HCT/Ps; including clinical site evaluation, training, implementation of J&J IM requirements, and oversight of processes related to HCT/P collection and processing. The CTL also leads resolution of complex issues involved in operational execution and delivery of patient products.
The CTL works with J&J IM Global Development, Global Clinical Operations, Drug Product Development, and Supply (DPDS), Clinical Supply Chain, External Quality, and the Oncology Therapeutic Area (TA) to provide input into cell therapy process development.
Cell Therapy Liaisons are organized regionally providing expertise tailored to the local practices and regulatory requirements.

REQUIREMENTS:

• Bachelor’s degree in a scientific, technical, or clinical discipline (e.g., medical technology, nursing, life sciences)
• A minimum of 3 years of experience in cell therapy in a clinical pharmaceutical setting, including stem cell transplant, apheresis collection, laboratory/cell manufacturing, quality, and/or cell therapy clinical operations
• A minimum of 5 years of experience in drug development
• Working knowledge and experience in the treatment of hematologic malignancies including at least one of the following: acute leukemias, non-Hodgkin’s lymphoma, and multiple myeloma
• Mastery of cell therapy standards and/or global pharmaceutical regulations (i.e., FACT/JACIE, GMP, GTP, GCP)
• Clinical Project Management skills and the ability to interface cross-functionally with clinical personnel
• Understanding of drug development and submission requirements
• Knowledge of drug manufacturing and logistics is preferred
• Ability to work independently and in a matrixed team environment
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution
• Effective leadership skills and proven ability to foster team productivity and cohesiveness are required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Excel)
• Must have excellent oral and written communication skills
• Possesses a strong quality mindset, effective leadership skills, and proven ability to foster team productivity and cohesiveness
• Ability to collaborate with all levels of management
• This position will require up to 25% travel.

• Reviews clinical protocols to ensure alignment with donor requirements, cell collection, product handling, tracking and traceability, and IP storage
• Reviews clinical site cell therapy capabilities (protocol feasibility assessments) for inclusion in clinical trials.
• Attends clinical site qualification visits for cell therapy trials to ensure compliance with relevant standards, regulations, and Janssen requirements.
• Supports the development, implementation, and training of the Cell Therapy Product Procedures Manual (CTPPM) for cell therapy clinical trials.
• Approves labels and onsite IP destruction.
• Leads Logistics Test Run (LTR) with clinical trial teams to ensure compliance with CTPPM.
• Supports cryopreservation site set up as per clinical trial protocols.
• Maintains regular contact with Clinical Supply Chain (CSC) for scheduling updates and COC/COI (Chain of Custody/Chain of Identity) requirements.
• Serves as an SME for issues and deviations from collection sites and cryopreservation locations, to assess the impact on upstream and downstream activities.
• Leads resolution of complex issues and deviations through a task force model.
• Monitors the progress of patients through their vein-to-vein journey in collaboration with functional areas and identifies/ resolves potential issues with a proactive planning mindset.
• Acquires and sustains advanced knowledge of cell therapy with respect to GTP, GMP, GCP, and the clinical trial setting.
• Evaluates current tissue and cell therapy regulation, FACT/JACIE standards, and other regional accreditation standards supporting cell and gene therapy to ensure Janssen complies.
• Provide guidance to global and local clinical teams in current cell therapy standards and regulations.
• Ensures coordinated contact and collaboration are maintained with other functions (e.g., Quality Assurance, Compliance, Clinical, Commercial, Sourcing, Supply Chain, Regulatory, and Manufacturing Operations).
• Participate in standing and ad hoc meetings.
• Other duties, as assigned.