Legend Biotech US
Operations Specialist
Legend Biotech US, Raritan, New Jersey, us, 08869
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 platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking an
Operations Specialist
as part of the
Technical Operations
team based in
Raritan, NJ.
Role Overview
This position will be responsible for providing operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Technical Operations in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for driving and implementing a wide variety of improvements, ensuring alignment in support of the overall objectives and priorities of the plant. The role will require communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.
Key ResponsibilitiesProvides general support to all Operating Areas, e.g. Manufacturing, Warehouse, Logistics, Support LabsCollaborates with Technical Operations who are responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data managementPartners with Operational Excellence to implement improvementsWrites, reviews, owns and updates SOPsOwns, provides assessments and takes actions in support of change controlsOwns CAPAs and associated project plansSupports events such as Root Cause Analysis (RCAs) and FMEAsParticipates in kaizens and other project initiativesSupports any business improvement effortsSupports permanent inspection readiness and actively supports internal audits and regulatory inspectionsProvides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocolsProvides input and supports improvements related to the aseptic environment and techniqueJob duties performed occasionally/situationally require exposure to and handling of biological materials and hazardous chemicalsRequirements
BS/BA required in technical discipline: Engineering, science or similar fieldGMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.Fundamental understanding of Lean principles and tools, Lean Six Sigma Green desirable3+ years of experience leading and/or supporting improvement or remediation effortsStrong understanding and proven application of problem-solving tools and techniquesDemonstrated experience ownings SOPs, change controls, investigations, CAPAs and other quality system actionsAbility to engage all levels of the organization, from site leadership to the shop floorProven experience working and leading in a matrix environmentAble to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environmentStrong ownership skills and ability to work independentlyStrong analytical, problem solving and critical thinking skillsExcellent organizational and communication skills
#Li-JK2
#Li-Hybrid
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
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 autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking an
Operations Specialist
as part of the
Technical Operations
team based in
Raritan, NJ.
Role Overview
This position will be responsible for providing operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Technical Operations in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for driving and implementing a wide variety of improvements, ensuring alignment in support of the overall objectives and priorities of the plant. The role will require communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.
Key ResponsibilitiesProvides general support to all Operating Areas, e.g. Manufacturing, Warehouse, Logistics, Support LabsCollaborates with Technical Operations who are responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data managementPartners with Operational Excellence to implement improvementsWrites, reviews, owns and updates SOPsOwns, provides assessments and takes actions in support of change controlsOwns CAPAs and associated project plansSupports events such as Root Cause Analysis (RCAs) and FMEAsParticipates in kaizens and other project initiativesSupports any business improvement effortsSupports permanent inspection readiness and actively supports internal audits and regulatory inspectionsProvides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocolsProvides input and supports improvements related to the aseptic environment and techniqueJob duties performed occasionally/situationally require exposure to and handling of biological materials and hazardous chemicalsRequirements
BS/BA required in technical discipline: Engineering, science or similar fieldGMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.Fundamental understanding of Lean principles and tools, Lean Six Sigma Green desirable3+ years of experience leading and/or supporting improvement or remediation effortsStrong understanding and proven application of problem-solving tools and techniquesDemonstrated experience ownings SOPs, change controls, investigations, CAPAs and other quality system actionsAbility to engage all levels of the organization, from site leadership to the shop floorProven experience working and leading in a matrix environmentAble to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environmentStrong ownership skills and ability to work independentlyStrong analytical, problem solving and critical thinking skillsExcellent organizational and communication skills
#Li-JK2
#Li-Hybrid
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.