Janssen Pharmaceuticals, Inc.is hiring for a CAR-T Cell Collection Operations, Manager to be located in Japan and reporting to Raritan, NJ.
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 [...] and follow us @JanssenGlobal.
The CAR-T Cell Collection Operations Manager manages, coordinates, and maintains a virtual supplier network of apheresis and cryopreservation starting material for commercial CAR-T products for Japan. Primary commercial CAR-T Janssen Supply Chain apheresis and cryopreservation Subject Matter Expert who leads technical relationship with Operating Company level Cell Therapy teams. Closely collaborates with Commercial CAR-T teams. Facilitates cell collection site certification activities related to apheresis and cell lab. Supports and/or provides training for technicians/nurses as needed. Facilitates, triages, and/or resolves near-real-time apheresis and/or cryopreservation quality investigation when required. Supports site education and answers on-demand questions related to apheresis and cell processing. Maintains awareness of industry standards related to apheresis and cell processing for CAR-T therapies.
Effectively collaborates with hospitals as suppliers and completes appropriate technical analysis to assure quality services. Systematically conducts, maintains, and manages key ‘hospital as supplier’ relationships. Maintains strong partnerships with other clinical and commercial operation groups in identifying options to improve performance. Implements programs to reduce supply base and achieve cost reduction goals. Coordinates breakthrough levels of logistic process and cost improvements and innovation. Supports business case and cost/benefit analyses for management team to facilitate sound business decision-making. Promotes use of Process Excellence tools at suppliers for continuous improvement. Supports and maintains supplier quality management program(s) and manage supplier relationships. Manages supplier capabilities including but not limited to capacity planning, tooling and resource investments including inventory management and service level agreements. Provides multisite and multi-sector support.
Manage and maintain commercial CAR-T apheresis and cryopreservation activities in support of CAR-T commercial supply chain activities.
Assist and manage the process of initiating and maintenance of the commercial cryopreservation site.
Provide technical oversight of apheresis and cryopreservation.
Facilitates and conducts qualification and training for Japan Act as primary POC for apheresis center, local cryopreservation cell laboratories, as well as, contracted third party apheresis/cryopreservation centers.
Refine and execute site selection, qualification and onboarding activities.
Develop working knowledge of Information Technology, Logistic transport and regulatory requirements affecting apheresis material and cryopreservation activities.
Execute issues management (related apheresis and local cryo), risk management, change management, recall.
Maintain metrics to monitor site performance.
Maintain infrastructure and capabilities to regionally support commercial activities.
Conduct Change Management for the process and/or equipment at each assigned site.
Ensure site qualification/certification completed and documented.
Oversee change management related to process and equipment changes that could impact Janssen product.
Ensure timely receipt of recall communications from apheresis centers and evaluate impact to product quality.
A minimum of a bachelor’s degree in a scientific or engineering discipline is required.
An Advanced degree (MS, PhD., Pharm. D., MD, RN) in a scientific discipline is strongly preferred.
A minimum of 4 years of relevant experience is required.
In depth working knowledge and conversant in APAC equivalent application of GTP, cGMP and/or GCP is required.
Working knowledge of PMDA health agency regulations regarding cell therapy or gene therapy is highly preferred.
Awareness of APAC health agency regulations is desired.
JACIE or FACT knowledge is preferred.
Working knowledge and experience with leukapheresis and cell processing is required.
In addition to Japanese, fluency in English is required.
Hospital or CRO/CMO experience is strongly preferred.
Project Management skills and the ability to interface cross-functionally with clinical personnel is preferred.
Working knowledge of Japanese and other Asia Pacific regulations is preferred.
Understanding of drug development and submission requirements is preferred.
Manufacturing and logistics understanding/experience is preferred.
Ability to work independently and in a matrixed team environment is required.
Ability to make decisions independently, 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.
Experienced quality assurance/compliance mindset is required.
Effective leadership skills and proven ability to foster team productivity and cohesiveness is required.
Work hours may require accommodation of up to a 13-hour time-zone difference with cryopreservation laboratory teams.
Travel may be required up to 30% of time.
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.
Primary Location Japan-Tokyo-To-Chiyoda-
Organization Janssen Pharmaceutical K.K. (7195)
Job Function Operations
Requisition ID 2105897830W