Associate Director, Manufacturing Systems IT

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 Associate Director, Manufacturing Systems IT as part of the IT Department team based in Somerset, NJ. 

Role Overview

The Associate Director, Manufacturing Systems IT will be responsible for setting the direction of manufacturing IT systems supporting clinical and commercial 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 ERP, LIMS, CMMS, ect.) related demand including building, testing, documenting, and implementing design changes.

Key Responsibilities  

• Manage the implementation of new and existing Manufacturing IT systems across Legend Biotech.
• Support review of change controls associated with manufacturing systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.
• Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the manufacturing IT system.
• Execute standardization plan and contribute to identifying opportunities to standardize.
• Test changes/enhancements through dry runs and receive feedback from manufacturing users, when required.
• Setup validation testing as appropriate for the manufacturing IT systems.
• Assist with User Acceptance Testing for system functionality changes.
• Collaborate/liase with appropriate manufacturing and/or site/global IT teams to ensure needs and requirements are accurate in the manufacturing 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 system.
• Provide ad hoc support to users for issues/questions.
• Communicate technical issues and activity status updates to team members/direct management.
• Process user account requests for system access.
• Maintain up to date knowledge on manufacturing 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.

Requirements

• Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 10 years’ experience
• Experience developing and deploying an Enterprise Manufacturing Execution System (MES)
• 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 (CMMS, LIMS, ERP, document management system).
• 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.
• Ability to execute changes in the manufacturing system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.
• 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 makes sound decisions within generally defined practices and pol