- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide technical expertise, train and manage an effective calibration program that supports daily clinical production and strategically prepares for commercial ... Company InformationLegend 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Leads and owns the Technical Training schedule weekly.Develops end-to-end training plans for new hires and supporting areas upon request.Assigns curricula to new ... hires according to learning journey.Maintains tracking and scheduling of yearly requalification's.Tracks progress of Operators and ensures on time completion of training.Track and maintains KPI's that impact site production capacity.Collaborates and stays… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Works with above plant functions to successfully implement and maintain tools, standards, policies and procedures in compliance.Handling day-to-day activities for ... BAS, EMS and other automation and controls system software, hardware and associated interfaces inclusive of data management, issues, deviations, corrections, remediation and improvementConducts local system data performance monitoring and analysis for BAS and… 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; ... Company InformationLegend 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Testing Scheduling Management: Configure, monitor, and maintain job scheduling systems (eg Smart QC, BINOC)Automation: Design and implement automated testing ... scheduling workflows to optimize system performance and efficiency alongside with analysts' tasks and timeMonitoring: Monitor test execution, adjust schedule as needed to address tests failures.Documentation: Maintain detailed documentation of tests schedules,… 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 ... improved business performance and increase utilization and skills of plant team membersLeads generation and alignment of integrated project plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk, cost, time are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Acts as a subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11 among others.Successfully implement and maintain company standards, policies and ... Company InformationLegend 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Working with integrated business planning team (IBP) and Vein to vein team (V2V) to plan, schedule and track the manufacture of autologous cell product batches at ... CMOMonitor the progress of product batches, identify and escalate deviation and other manufacture issuesCollect, calculate the KPI, and mitigate/remedy gaps of the CMO manufacture performanceCollaborating with procurement team/financial team on new orders,… 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)
- …Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process ... Company InformationLegend 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manage and oversee all technical side of the CMO activities: deviation investigation, change control and risk assessment, process improvement, continuous process ... validation.Support commercial and developmental batches as a technical PIP as neededProvide timely and accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager and cross functional stakeholders.Monitor manufacture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Collect, analyze critical process parameters (CPP) data, in-process testing data, and drug product release data to identify out-of-trend performance.Assist ... investigation and root cause analysis by performing data trending and statistical analysis.Represent CMO MSAT team in global MSAT forum.Work closely with internal site MSAT team to compare the site performance and identify opportunities to improve process and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Successfully support the implementation, execution, and improvement of the internal audit process.Support the planning and execution of internal audits for all ... quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through to ensure satisfactory resolution and closure of each internal audit.Coordinate front room/ back room activities for health authority audits and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Demonstrates professional execution of the planning, development, and implementation of construction and/or repair programs for engineering driven initiatives. Serves ... as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and installations. Identifies, investigates, and analyzes a wide range of complex facilities, utilities,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …As an Asset / Reliability 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. ... This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.Key Responsibilities Read, interpret and revise documents such as SOPs, work instructions.Develop positive relationship with the QA team,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic ... chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …include providing quality oversight over process improvement projects within a cell therapy manufacturing facility to support both clinical and commercial ... requirements in a sterile GMP environment. This role will support quality activities for continuous improvement efforts, site escalations, and quality projects.Key Responsibilities Provide quality and compliance input for identified continuous improvement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Advanced degree in related field (data science, computer science, mathematics, statistics, biostatistics, operations research, quantitative MBA, or similar) with 8 ... About the Department The Finance, Insights & Enterprise Solutions department brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance, Insights & Enterprise Solutions works closely… more
- Genmab (Plainsboro, NJ)
- …of the role will include, but is not limited to: Act as US regulatory lead and FDA contact person for assigned project(s) and be responsible for the implementation ... At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our… more
