reputed company is hiring: Manufacturing Engineer in Raritan

Company 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 reputed company of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.reputed company entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of reputed company, to jointly reputed company 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.reputed company is seeking an Manufacturing Engineer as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe Manufacturing Engineer will be part of the Technical Operations team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also reputed company processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies. Will participate and assist in technical transfer activities into and out of the Raritan facility.Key ResponsibilitiesProvide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology to support technical activities for transfers into and out of the Raritan facility.Support and identify opportunities for process improvements, support improvement projects, and drive implementation strategy. Ensure seamless flow of knowledge and information across functions, and with other sites reputed company applicable.Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.Write and/or review manufacturing process transfer plans, protocols, and reports.Design studies, draft protocol, reputed company execution and draft reports necessary to support the implementation of process improvements.Provide technical/scientific recommendations and support and manage applicable change controls.Technical assessor of change controls.Provide review of process flow diagrams as well as protocol and reports from development.Support the implementation of manufacturing and process improvement strategies through cell therapy manufacturing process design qualification, vendor evaluation, and reputed company system reputed company engineering support for GMP manufacturing of engineered autologous T cell therapy products.Work closely with cross-functional teams to design and implement cell therapy processes for cell therapy platforms.Work cross-functionally across Technical Operations and reputed company with external vendors to drive the design and implementation of automation platforms and/or new raw materials and consumables for cell therapy development and manufacturing.Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process.Draft Process Risk Assessments for implementation of process changes.RequirementsBS/BA required in technical discipline: Engineering, science or similar field.A minimum of five (5) years experience reputed company a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.Support facility fit assessments for evaluation of changes between sending and receiving sites.Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless implementation of technical transfer activities and/or process improvements.Work closely with the development organization to ensure translation of changes from concept to implementation.Support writing of MBRs and SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be reputed company to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, reputed company and quality compliance.Provide technical expertise in the evaluation of potential process changes for effectiveness, value, and risk.Work cross-functionally across Technical Operations and reputed company with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.reputed company technical feasibility studies reputed company to process improvement and implementation of new manufacturing technologies.Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs reputed company in a matrixed environment.Strong analytical, problem solving and critical thinking skills and the ability to reputed company as a change agent to promote flexibility, creativity, and accountability.Language: English.reputed company is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is reputed company?s policy to ensure equal employment opportunity without discrimination or harassment based on race, reputed company, religion, sex (including pregnancy, childbirth, or reputed company medical conditions), sexual orientation, gender identity or expression, age, disability, national reputed company, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.reputed company maintains a drug-free workplace.Benefits:Health InsuranceDental InsuranceVision InsuranceLife InsuranceMatched 401KFlexible Spending AccountHealth Savings AccountAD&D InsuranceShort-Term DisabilityLong-Term DisabilityPaid Maternity LeavePaid Paternity LeavePet InsuranceCritical Illness InsuranceHospital Indemnity InsuranceAccident InsuranceLegal InsuranceCommuter BenefitsEmployee Assistance ProgramSeniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering and Information Technology #J-18808-Ljbffr Apply Job!