12 jobs found in raritan

Legend Biotech USA Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ . Role Overview The Operations Support Specialist will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule. Key Responsibilities Support process operations by performing support specific and real time floor service tasks (i.e., kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior for cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format. Perform tasks on time in a manner consistent with safety policies, quality...

Legend Biotech USA Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for management and delivery of the integrated project and program plans in the plant, ensuring alignment in support of the overall objectives and priorities of the plant. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget project deliverables. The role will require proven leadership and expertise...

Legend Biotech USA Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role Overview The MES Engineer will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X). Key Responsibilities Support eBR development, modeling, and deployment in MES Coordinate with other departments to gather user requirements, guage effort, and deliver robust, right first time EBR designs. Participate in design...

Legend Biotech USA Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role Overview This position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require technical expertise and troubleshooting ability to drive effective and robust production, testing and release of product to patients. This person must be able to work 3rd shift/overnight hours....

Legend Biotech USA Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and...

Legend Biotech USA Legend Biotech is seeking an Operations Associate (1st and 2nd shift openings available) as part of the Technical Operations team based in Raritan, NJ . Role Overview This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Key Responsibilities Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum. Execute manufacturing activities common to cell culturing, purification, aseptic processing, and...

Legend Biotech USA Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to...

Legend Biotech USA Role Overview Legend Biotech is seeking a C&Q Intern as part of the Commissioning and Qualification (C&Q) team based in Raritan, NJ for our 2025 Summer Internship Program, which will run from June 9th, 2025, to August 15th, 2025. The intern will work 40 hours per week, Mon - Fri, requiring that the intern be onsite 5 days per week. The intern will perform C&Q support duties that will include coordinating the work of cross-functional team members, binder archival/scan, creation/update of data base. Key Responsibilities Support creation/update of PVR (Periodic Validation Review) data base and PV (Performance Verification) load technical document Support scanning of the binders Support C&Q team member and learn about Qualification process Support update of Equipment release document Help with co-ordination of activities for C&Q tasks Help with C&Q technical documents template updates Help with compilation of...

Legend Biotech USA Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role Overview The Manager of CAR-T Investigations will be part of the Operations Investigations team and will be responsible for managing and leading different investigations work-cells, drive investigations to closure, support escalations, monitor and improve performance metrics for team. They will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies. Key Responsibilities Individual will lead a team to support manufacturing investigations, capacity planning, hiring, development, and performance management of its direct reports. Monitor day to day execution of investigations, maintain investigations metrics and take necessary actions to sustain metrics targets. Reports to management on trending and status as requested. Identify and implement process...

Legend Biotech USA Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role Overview This position is responsible for the qualification of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program overseeing facilities, utilities, and equipment for Legend Biotech. The position is responsible for ensuring that the qualification activities are performed within an appropriate level of GxP compliance. This individual will need to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies within cell therapy Technical Operations. Key Responsibilities Interface between the Engineering group and the operating...

Legend Biotech USA Legend Biotech is seeking a Metrology Support Specialist as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for metrology support for instrument and mechanical system scheduling, planning, and work order management for cGMP Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production. This position will also be responsible for supporting, planning and scheduling facility & engineering related activities. The role will require proven leadership and expertise that drives effective communication,...

Legend Biotech USA Legend Biotech is seeking a Critical Equipment Expert as part of the Global Operations team based in Somerset, NJ. Role Overview This position will be responsible for calibration and maintenance support of mechanical system operations for cGxP Clinical Cell Therapy Manufacturing and R&D Laboratories. This individual will partner with various functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGxP requirements. They will require technical expertise and troubleshooting ability to support the Clinical Production Facility and R&D laboratories. This role will focus on critical operations equipment for reliability, calibration and PM completion, troubleshooting, scheduling, spare parts, and compliance to continually support site needs. This role supports operational activities, occasionally these activities will require support outside of the typically work schedule,...