- 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 ... Company Information 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… 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Develop User Requirement Specifications (URS) and oversee the management of equipment qualifications. Provide support for data integrity assessments within the ... laboratory. Take the lead in managing Equipment Lifecycle Management processes, including overseeing change control procedures. Document and manage records for corrective and preventative actions, ensuring compliance with regulatory standards. Draft, review,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Leads, directs, coaches, and develops an effective maintenance and metrology team that supports daily clinical production and strategically prepares for commercial ... supply of a CAR-T product Manages, plans, coordinates, staffs, and prepares timely execution of daily activities related to facility operation, calibrations and corrective, preventative and predictive maintenance, and repair Ensures proper materials, parts and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strategic Process Improvement Planning: Develop and implement a comprehensive plan to reduce vein to vein time, aligning with the overall strategic goals of the ... Company Information 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… 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)
- …Your primary role will be to design, implement and deploy a global standard and data creation workflow process that supports GMS business activities, and in line with ... Company Information 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide technical and program management to drive an analytical automation platform solution for a best-in-class CAR-T product. Development of an automation concept ... through detailed execution planning activities and milestone Program management leadership to drive the strategic plans/business cases to support selected platform concept, detailed project schedule for implementation, vendor coordination and cross functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide technical and program management to drive a process automation platform solution for a best-in-class CAR-T product Development of an automation concept ... through detailed execution ,planning activities, and milestone. Program management leadership to drive strategic plans, business cases to support selected platform concept, detailed project schedule for implementation, vendor coordination and cross functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant Manages multiple and complex CQV ... projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks Supports and/or owns technical and quality investigations, CAPAs and corrections Develops and performs any required remediation efforts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Perform peer review/approval of laboratory data including but not limited to eLIMS Electronic Notebooks, laboratory formbooks, training formbooks, instrument ... Company Information 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology to support ... Company Information 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… 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)
- …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 Responsibilities Leads, coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be providing technical content/strategics plans as part of collaborative working groups with cross functional partners (ie and competitiveness) to develop ... process automation and improve delivery/logistics to patient (ie reduce TAT) allowing Legend to maintain a competitive advantage in the market place. Key Responsibilities Additional responsibilities include; Management oversight and/or contribute to strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight for the manufacturing process, equipment, and associated deviations and investigations 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 operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system. Ensure alignment ... with GMP regulations and organizational objectives in all investigation activities. Standardize and improve the quality of investigations across the organization. Provide Technical Oversight: Offer technical expertise and guidance to investigation teams in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for leading a team of microbiology data reviewers supporting the reviewing microbiology data and documentation generated from the Environmental Monitoring program, ... drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data Reviewer will also be responsible for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. ... This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply. Key Responsibilities Support compliance activities for site… more
