- Legend Biotech USA, Inc. (Raritan, NJ)
- …Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.Lead a ~250+ organization responsible for either ... the non-sterile or sterile manufacturing processes in a 24/7 operation and be responsible to assign personnel to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and execution of a unified LinkedIn strategy that spans multiple regions, ensuring it ... 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)
- …Lead/contribute to DS R programming system technology development: Lead/contribute to the R programming system development. Act as R programming SME and functional ... 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
- 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)
- …Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, ... 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)
- …Serve as a subject matter expert for warehouse operations and perform daily warehouse operation processes, including inbound, outbound, storage, and replenishment. ... Work with inventory management systems and execute cycle count and reconciliation activities to ensure inventory accuracy. Support the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Represent MSAT at joint technical and CMC committeesPartner closely with senior Janssen technical team to achieve global alignment on all technical Carvykti ... scopeProvide technical direction and support of an expanding global manufacturing network for best-in-class CAR-T product.Work collaboratively with internal and external partners to drive global process platform improvements and cost reduction initiativesDrive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position oversees ICSR Standards activities, projects, and procedures. This level interacts within global CSPV and with CROs, vendors, and partners; and ... participates on interdepartmental study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP ... environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA program for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, ... both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process ... 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 eBR development, modeling, and deployment in MESCoordinate with other departments to gather user requirements, guage effort, and deliver robust, right first ... 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)
- …for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy ... manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... 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)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... university) Bachelor's Degree in a scientific, healthcare or related discipline required Experience QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial supply ... of a CAR-T productPlans, coordinates, and performs timely execution of daily activities related to calibration and instrumentationEnsures proper materials, tools, standards, parts and spare parts are identified and availablePerforms work review, approval and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) ... according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …below with or without a reasonable accommodation.Education (from an accredited college or university)Bachelor's Degree in Computer Science, Life Science, Engineering, ... 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)
- …CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and ... 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)
- …- Group strategy: Sets the vision and strategy for the group including overall vision for a robust risk assessment, mitigation, central (statistical) monitoring and ... 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
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