Tbwa Chiat/Day Inc
Associate Director, Manufacturing Operations Lead
Tbwa Chiat/Day Inc, Trenton, New Jersey, United States,
Associate Director, Manufacturing Operations Lead
Somerset, New Jersey, United StatesCompany InformationLegend 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
Associate Director, Manufacturing Operations Lead
as part of the
Technical Development
team based in
Somerset, NJ.Role OverviewThe Associate Director, Manufacturing Operations Lead will be responsible for performing the activities necessary to start up and run a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell therapy pipeline assets to patients in need. The successful candidate will first collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate the facility for the purpose of producing Phase 1 products. The following activities will include implementing manufacturing, testing and release for cell therapy product candidates.Key ResponsibilitiesCreate procedures necessary to operate the GMP facility in a Phase 1 manner.In collaboration with the development and quality teams, define the layout and activity flow for the facility along with appropriate classification.Establish relationships with outsourced vendors such as environmental monitoring.Establish a training program for all staff performing GMP activities.Lead a cross-functional team to design and perform qualification activities such as aseptic process simulations, equipment qualification, etc.Participate in project teams to design and execute process and analytical method transfer.Participate in project teams to design and deliver IND-enabling data for each cell therapy asset.Direct routine manufacturing and testing of cell therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations.Ensure the required quality and safety standards are achieved and maintained with respect to GMP operating procedures, batch manufacturing documentation, GMP suites and compliance with the relevant phase-specific regulatory requirements.Requirements
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.Knowledge and experience with cell therapy manufacturing processes and tests.Experience establishing and operating in a GMP environment.Familiarity with cell therapy manufacturing and testing equipment.Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient.Experience working in cross-functional matrices.Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.Familiarity with aseptic processing.Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.Legend Biotech maintains a drug-free workplace.
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Somerset, New Jersey, United StatesCompany InformationLegend 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
Associate Director, Manufacturing Operations Lead
as part of the
Technical Development
team based in
Somerset, NJ.Role OverviewThe Associate Director, Manufacturing Operations Lead will be responsible for performing the activities necessary to start up and run a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell therapy pipeline assets to patients in need. The successful candidate will first collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate the facility for the purpose of producing Phase 1 products. The following activities will include implementing manufacturing, testing and release for cell therapy product candidates.Key ResponsibilitiesCreate procedures necessary to operate the GMP facility in a Phase 1 manner.In collaboration with the development and quality teams, define the layout and activity flow for the facility along with appropriate classification.Establish relationships with outsourced vendors such as environmental monitoring.Establish a training program for all staff performing GMP activities.Lead a cross-functional team to design and perform qualification activities such as aseptic process simulations, equipment qualification, etc.Participate in project teams to design and execute process and analytical method transfer.Participate in project teams to design and deliver IND-enabling data for each cell therapy asset.Direct routine manufacturing and testing of cell therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations.Ensure the required quality and safety standards are achieved and maintained with respect to GMP operating procedures, batch manufacturing documentation, GMP suites and compliance with the relevant phase-specific regulatory requirements.Requirements
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.Knowledge and experience with cell therapy manufacturing processes and tests.Experience establishing and operating in a GMP environment.Familiarity with cell therapy manufacturing and testing equipment.Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient.Experience working in cross-functional matrices.Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.Familiarity with aseptic processing.Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.Legend Biotech maintains a drug-free workplace.
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