- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support process operations by performing support specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Participate in Vein-to-Vein, S&OP (CRR), Site Supply Chain, and Operations meetings (eg, Production Ramp Up plan) to assess manufacturing constraints and prioritize ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead global sourcing for assigned direct materials category for a fast-growing commercialized CAR-T product.Develop a long-term category strategy aligned with product ... growth and supplier diversification.Support building a high-performing global sourcing organizationAssess and periodically update risk scores for BOM and other high-risk materials.Co-develop sourcing scoreboards, KPIs, and metrics to enhance visibility across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).Ensure appropriate Corrective and Preventative Actions (CAPA's) are ... developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual's primary responsibility will be support of manufacturing process optimization through process modelling, new technology integration, and various site ... expansion initiatives.Establish relationships and work cross functionally with local and global stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality.Work closely with Sr. Manager, Strategic Initiatives to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will include but are not limited to:Work with end users to define MES change requirementsSupport eBR development, modeling, and deployment in MESParticipate in design ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supervises an effective maintenance team that supports daily production of a CAR-T manufacturing facility.Maintains safety standards and training in the department; ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead manufacturing and cross functional investigations from end to end.Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.Work cross ... functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and ensuring compliance.Support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.Serves as Subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the ... optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality ... oversight across all Medical Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …As a Facility Engineer you are responsible for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to ... make the performance and behavior of the equipment more reliable. The focus will often be on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Be part of the manufacturing operations team responsible for production of autologous CAR-T productsSupport the Gowning Training Program responsible for clinical and ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead projects for the implementation of site strategic initiatives and capacity expansion activities from identification through implementation.Work with ... cross-functional teams to develop a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation to support site ramp up plans.Monitors capacity enabling resource… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Interpret and analyze demand and usage of various materials including (but not limited to) critical supplies, clinical materials, components and ... consumables.Participate in regular Site Supply Chain / Planning meetings (eg S&OP and LRFP) to evaluate manufacturing plans to ensure inventory coverage and supply readiness.Monitor supplier execution and deliverables of goods and services aligned with scope… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsible for managing the current MES system that drives ongoing manufacturing and system upgrade/improvement projects. MES ownership includes but is not limited ... to the following:Plans, leads, develops, provides expertise, trains, coaches, drives and manages an effective, holistic continuous improvement, problem solving and management program to improve process execution and system utilization of the MES.Implement a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Helps to develop and support implementation of a project management office (PMO) with tools such as project portfolio management to prioritize projects to deliver ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
