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 Head of Pipeline Systems IT as part of the IT team based in Somerset, NJ. Role OverviewThe Head of Pipeline Systems IT will be responsible for setting the direction of R&D, Early Drug Discovery, Clinical Operations, and Technical Development (Process Development & Analytical Development) IT systems supporting research and development and clinical manufacturing, as well as ensuring quality and promoting efficiency of IT projects and deployment. In addition, the role will be responsible for driving solutions to Enterprise IT System (like LIMS/ELN, Veeva, etc.) related demand including building, testing, documenting, and implementing design changes.
Key ResponsibilitiesManage the implementation of new Pipeline IT systems across Legend Biotech.Support review of changes associated with IT systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.Execute standardization plan and contribute to identifying opportunities to standardize.Test changes/enhancements through dry runs and receive feedback from business users, when required.Assist with User Acceptance Testing for system functionality changes.Collaborate/liaise with appropriate site/global IT teams to ensure needs and requirements are accurate in the pipeline systems.Evaluate, recommend and implement processes to improve compliance and the efficiency of manufacturing operations to support product release, new products, and key performance indicators/metrics.Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.Train users on overview of the system.Provide ad hoc support to users for issues/questions on the lab system.Communicate technical issues and activity status updates to team members/direct management.Maintain up-to-date knowledge on R&D IT functionality and apply functionality to improve system use and ensure efficient user experience within the systems.Participate on/Lead teams in support of business process improvements/operational excellence.Provide support for internal compliance and regulatory agency inspections as required.First point of contact for business partners.RequirementsMinimum B.S. degree in a relevant scientific, computer or engineering program area with at least 12 years' experience.Experience developing and deploying lab IT systems.Knowledge and in-depth understanding of biopharmaceutical or cell therapy manufacturing.Proficient knowledge and understanding of system interfaces and impact of changes to each other a plus.Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.Demonstrated ability to work independently to complete assignments within defined time constraints.Respond to system issues and troubleshoot to identify cause.Ability to interpret and apply GxPs, regulatory requirements.Must have knowledge of software development lifecycle (SDLC) and of computer systems validation (CSV).Ability to exercise judgment and make sound decisions within generally defined practices and policies to independently develop approach/solution. Consult with technical if needed.Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team. Self-directed with a high degree of professional integrity, very organized, and detail-oriented.Demonstrated problem-solving ability, attention to detail, and analytical thinking skills.Strong interpersonal, oral and written communication skills are essential. Must contribute to a team-based, collaborative and positive environment, clarity of purpose and high commitment to business goals.Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.Knowledge of enterprise manufacturing, lab systems and Quality Management concepts that are used in Bio Pharma industry.
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