- 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)
- …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)
- …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. (Philadelphia, PA)
- …Lead and oversee all toxicology strategy and execution for preclinical development programs in cell and gene therapy.Design, implement, and interpret nonclinical ... 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)
- …Design, build, and maintain interactive dashboards and reports in Power BI to support FP&A deliverables such as KPI reporting, monthly management reporting, budget ... vs. actuals (BvA), rolling forecast analysis, and long-range financial planning (LRFP).Leverage low-code/no-code features (DAX formulas, Power Query, visualization tools) to develop scalable and user-friendly dashboards.Contribute to the Global Competitiveness… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Review documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).Review documentation for miscellaneous activities ... executed in accordance with Good Documentation Practices (GDP).Work in a team based, cross-functional environment to complete tasks required to meet all business objectives.Perform regular administrative duties to maintain all manufacturing record which will… 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)
- …for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy manufacturing. This includes hiring, ... development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.Key… 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 ... environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents… 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
- 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. (Detroit, MI)
- …Identify KOLs within the assigned territory and establish and maintain scientific relationships with KOLs in both academic and community institutions.Execute ... activities at the assigned territory level in full alignment with Medical Affairs strategies and tactics.Assist in the oversight of Legend Biotech sponsored clinical trial sites to include, but not limited to, site identification, patient accrual discussions,… 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 LRP) to evaluate manufacturing plans to ensure inventory coverage and supply readiness.Monitor supplier execution and deliverables of goods and services aligned with scope of… more
