- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist as part of the Technical Operations team based in Raritan,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a ... projects to drive continuous improvements and efficiencies within cell therapy Technical Operations. Support organizational design updates, operations… more
- Insmed Incorporated (San Diego, CA)
- …with FDA and with other Health Authorities (such as EMA and PMDA) Support and monitor the development of new/revised regulatory requirements or procedures and ... potential impact to key collaboratorsMentor junior regulatory professionals and support a culture of continuous learning, cross-training, and operational… more
- Insmed Incorporated (San Diego, CA)
- …regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by ... Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and their outcomes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements.Work closely with cross-functional teams to design and implement cell therapy processes, manage equipment qualification strategy, and support ... to drive the design and implementation of automation platforms for cell therapy development and manufacturing.Primary role is to support deviation investigation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support ... quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy .Experience with quality support in clinical manufacture is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial ... site.Oversee metrics, trending, and reporting of relevant quality systems records. Support CAPA site governance programDrive continuous improvement of quality systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …qualification activities for facility, equipment, systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial ... and approving, work orders, qualification protocols, and reports in support of equipment and facility qualification, process validation, maintenance activities,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team of maintenance specialists and partner with cross functional areas in support cell therapy production for clinical and commercial patients.Key ... HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support , Facilitiesand Engineering, MS&T/Finance)RequirementsEducation: High school diploma or GED… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This ... with Training team members in collaboration with management in Operations to support personalized cell therapy production through safe and compliant operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …noon-8:30pm). This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and ... NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and...facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will partner with Plant Leadership and all applicable site functions in support of personalized cell therapy production through safe and compliant ... NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Facility Engineer will be responsible for ensuring equipment/systems required to support an expanding Cell Therapy facility is appropriately purchased, ... This individual will be an integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be required to collaborate within a cross functional team of experienced cell therapy professionals whose responsibility it is to deliver a best-in-class high volume ... global commercial program by adhering to industry best practices and sound cell therapy technical principles and deliver a process platform is robust and consistent.… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …help advance our pipeline programs. As part of Legend Biotech-a leader in cell therapy with the commercial CAR product CARVYKTI and a strong pipeline-you will play a ... the value of collaboration and teamwork, and provide expertise and team support in a fast-paced environment.Key Responsibilities Be able to work independently under… more
- Merck & Co. (Rahway, NJ)
- …management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to ... in partnership with the CTT.The CQOMs within a specific therapy area will collectively and periodically (eg quarterly) perform...knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drive the design and implementation of new system updates for cell therapy development and manufacturing.When necessary, support studies related to process ... responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Chain, and other operational groups.Hands-on experience with cell and gene therapy components and associated manufacturing processes.Provide support in project ... is responsible for leading global sourcing activities for direct materials in support of a rapidly expanding, commercialized CAR-T product portfolio. This position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role ... issues resulting in the delay of investigation closure and product release. Support regulatory inspections and audits by ensuring inspection readiness within facility… more
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