Janssen Research & Development LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T and Apheresis Site Liaison (CASL). This position can be located remotely within the United States.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.
The CAR-T and Apheresis Site Liaison (CASL) will serve as a cross-functional, point of contact within Janssen for operational and technical aspects of collections and cryopreservation of apheresis cells used to manufacture chimeric antigen receptor T cells (CAR-T). This individual will provide technical and operational support to clinical sites participating in Janssen global CAR-T clinical trials. CASLs are organized regionally providing expertise tailored to the local practices and regulatory requirements.
The CASL will work with the Janssen Global Clinical Development Organization (GCDO), Drug Product, Development, and Supply (DPDS), Janssen Supply Chain, External Supply Integration Quality Assurance (ESIQA) and the Oncology Therapeutic Area (TA) to provide input into CAR-T product and process development.
Clinical site assessment and start up for Chain of Identity (COI), collection, transport, shipment and cryopreservation (of peripheral blood mononuclear cells or PBMCs) activities used in CAR-T trials.
Support clinical site qualification and training for apheresis collections and local cryopreservation.
Coordinate, deliver, and document site training for local cryopreservation of apheresis products.
Provide on-site support to answer questions and ensure appropriate support from subject matter expert.
Support selection, qualification and operations for central cryopreservation sites.
Evaluate FACT/JACIE or other regional accreditation standards supporting cell and gene therapy.
- Issue Management
Support relevant Janssen functions when issues arise at clinical sites related to collection and cryopreservation of apheresis products.
Assist with triage of issues and questions originating at sites (clinical, central cryopreservation and manufacturing) to GCDO and TA.
- Provide feedback on investigations, as needed.
- Support coordination of efforts to resolve issues
- Work with multidisciplinary teams (GCDO, DPDS, ESIQA, and JSC) to support site CAR-T operations.
Acquire and sustain advanced knowledge of CAR-T cell therapy with respect to GTP, GMP, GCP and the clinical trial setting.
Ensure Janssen management is kept informed of all critical and major issues.
Ensure coordinated contact and collaboration is maintained with other functions (e.g. Commercial, Quality Assurance, Compliance, Clinical, Sourcing, Legal, Supply Chain, Regulatory, Manufacturing Operations).
Maintain current knowledge of regulatory and industry requirements for cell and gene therapy.
- Participate in standing and ad hoc meetings.
- Other duties, as assigned.
A minimum of 3 years of experience in cell and gene therapy in a clinical or pharmaceutical setting is required.
Working knowledge and experience in the treatment of hematologic malignancies, including at least one of the following: acute leukemias, non-Hodgkin’s lymphoma or multiple myeloma, is required.
Experience in stem cell transplant apheresis collection, quality or laboratory/manufacturing and/or working with local or international blood/tissue requirements is required.
Working knowledge of cell therapy standards and pharmaceutical regulations (i.e. FACT/JACIE, GMP, GTP, GCP) is required.
Clinical Project Management skills and the ability to interface cross-functionally with clinical personnel is required.
Knowledge of drug development and submission requirements is required.
Experience in Drug Manufacturing and logistics preferred.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
Must have excellent oral and written communication skills.
Must have the ability to adapt to changing situations, prioritize tasks according to objectives, and provide problem resolution.
Must have a strong quality mindset, effective leadership skills and proven ability to foster team productivity and cohesiveness.
The ability to collaborate with all levels of management in a matrix environment is required.
- This position will require up to 25% travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Research & Development, LLC (6084)
Clinical Research non-MD