Janssen Pharmaceutical is currently recruiting for a CAR-T Cell Collection Operations, Senior Manager to be located in Raritan, NJ and/or working remotely from any U.S. locations.
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. Janssen Supply Group LLC. is part of the Janssen Pharmaceutical Companies.
The CAR-T Cell Collection Operations Senior Manager identifies, develops, and implements virtual supplier network of apheresis and cryopreservation starting material for commercial CAR-T products. 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. Appropriately balances the requirements at apheresis and cell processing sites as it relates to multiple in-flight programs/indications: early development, clinical trials, and commercial activities. Facilitates cell collection site certification activities related to apheresis and cell lab. Coordinates and site audits for apheresis and cell lab, supports and/or develops SOP and training for technicians/nurses as needed. Facilitates 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. Provides key leadership in shaping industry standards related to apheresis and cell processing for CAR-T therapies, using input from multiple stakeholders (apheresis site, healthcare provider, manufacturing, logistics, providers, etc.).
Effectively collaborates with hospitals as suppliers and completes appropriate technical analysis to assure quality services. Conducts health agency and cell therapy industry research and market analysis. Systematically develops, leads, implements, manages, promotes key ‘hospital as supplier’ relationships. Builds strong partnerships with other clinical and commercial operation groups in identifying options to improve performance. Develops and implements programs to reduce supply base and achieve cost reduction goals. Delivers breakthrough levels of logistic process and cost improvements and innovation. Develops 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. Develops and implements 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. Gives multisite and multi-sector support.
• Identifies, develops, and implements commercial CAR-T apheresis and cryopreservation activities in support of CAR-T commercial supply chain activities.
• Facilitates and conducts qualification and training for each site.
• Act as primary POC for apheresis center, local cryopreservation cell laboratories, as well as, contracted third party apheresis/cryopreservation centers.
• Build upon and refine site selection, qualification and onboarding activities
• Develop working knowledge of Information Technology, Logistic transport and regulatory requirements affecting apheresis material and cryopreservation activities
• Create Process - issue management (related apheresis and local cryo), risk management, change management, recall
• Define metrics to monitor site performance
• Create/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 prior to FPI
• 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 8 years of relevant experience is required.
• In depth working knowledge and conversant in GTP, cGMP or GCP is required.
• Working knowledge and experience with leukapheresis and cell processing is required.
• Working knowledge and experience in the treatment of hematologic malignancies including acute leukemias, non-Hodgkins lymphoma and multiple myeloma is preferred.
• Stem cell transplant or apheresis experience and working with health agency established blood/tissue requirements is preferred.
• Expertise in evolving health agency regulations regarding cell therapy or gene therapy is preferred.
• Project Management skills and the ability to interface cross-functionally with clinical personnel is required.
• 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.
• Proficiency in Microsoft Word, Excel, PowerPoint; Microsoft project is required.
• This position is located in Raritan, NJ or any other J&J facility in the US, and may require travel up to 30% of time both internationally and domestically.
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.
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Internal Number: 9304200729
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