- Legend Biotech USA, Inc. (Raritan, NJ)
- …The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust training, ... regulatory compliance, team readiness, and processing of product prior to release to patients.Key ResponsibilitiesLeads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key ... Responsibilities Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.Ensure testing is completed in compliance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will include but are not limited to:Lead project core teams to ensure on time project delivery.Leads generation and alignment of MES and/or IT project plans across ... functional teams Defines the interdependent deliverables for MES and/or digital projects and ensures that quality, risk, cost, time are managed within the overall approved plan to drive delivery of project milestones and objectives on time and on budget.Drives… 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)
- …for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a ... 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
- 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
- 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)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot ... 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)
- …of the position.Is frequently required to communicate with coworkers.While performing the duties of this job, the employee is regularly required to stand; walk; ... climb, bend and stoop; and reach with hands and arms.Ability to lift 25 lbs.Needs to perform gowning procedures to work in manufacturing core.#Li-DD1#Li-OnsiteThe anticipated base pay range is$57,445—$75,396 USDBenefitsWe are committed to creating a workplace… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manage the global Compliance leads to ensure harmonization and alignment across all functions and sites.Support the development of the GMP Compliance program related ... 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)
- …Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and ... material/ raw material sub-teams to support global best practicesPartner closely with Legend and Janssen partners to complete supporting technical documentation with an eye for global alignment templatesWork collaboratively with internal and external partners… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages multiple and complex CQV ... projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required remediation efforts and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust training, ... regulatory compliance, team readiness, and processing of product prior to release to patients.Schedule: Mon-Fri, 2nd ShiftKey Responsibilities Leads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Prepares and reviews documentation independentlyResponsible for QC sample and retain managementKnowledge and understanding of current Good Manufacturing Practices ... (cGMP) related to the QC laboratory and ability to identify gaps in processes or systemsProficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)Prepare documents and coordinate Sample… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and ... commercial operations in a controlled GMP environment.Key Responsibilities Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.Review/complete routine CAR-T manufacturing nonconformance/deviation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support and lead the execution of Indirect Procurement strategies at the site level across categories including, but not limited to:Materials: Lab supplies, PPE, MRO, ... 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 compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.Collaborate with site personnel to provide ... guidance and determine resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Review and approve manufacturing procedures.Support regulatory inspections and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …The candidate will work closely with our Commercial, Supply Chain, Production Planning, and Manufacturing teams to assist in executing the current monthly IBP 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)
- …Lead and oversee all engineering management including asset/reliability, data systems/automation and Commissioning/Qualification.Support the development 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
