- Eclaro (Manville, NJ)
- …Content Management Capabilities: References and Core Claims: Assist with setup of centralized reference & core claims library, collaborating with markets/brands on ... Reference and Core Claims Content Central Librarian Job Number: 24-01913 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Reference and Core Claims Content Central Librarian for our client in Lawrence Township, NJ.… more
- Eclaro (Manville, NJ)
- …Critical review and recommend changes to promotional materials/activities to ensure balance of the messages, medical accuracy, and appropriateness of the content of ... Scientist Associate Job Number: 24-03333 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Scientist Associate for our client in Lawrence Township, NJ. ECLARO's client is a leader in the Biopharmaceutical Industry,… 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)
- …for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial ... operations in a controlled GMP environment.Key Responsibilities Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial… 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)
- …As a management member of the Warehouse team, participate in governance structure design, decision making process, as well as performance management and initiatives ... related to the continuous improvement of the warehouse operations.Responsible for hiring, development, and performance management of staff (including shift teams) within the warehouse as well as the establishment of key performance indicators for Warehouse… 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)
- …for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP ... 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)
- …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 tracking and managing all CAPA's, corrections and change controls, developing microbiology procedures and methods, ownership of various QC Microbiology 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
