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 a Lab System Specialist as part of the IT team based in Somerset, NJ.
Role Overview
The Lab IT Systems Specialist will be responsible for administrating and maintaining LabVantage LIMS and ELN, and various other lab applications used in R&D, pre-clinical, clinical operations and technical development.
Key Responsibilities
- Actively manage all aspects of the LabVantage LIMS and ELN systems.
- Create and maintain master data/static data in lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
- Support review of change controls associated with lab 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 lab system.
- Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up.
- Execute standardization plan and contribute to identifying opportunities to standardize.
- Test changes/enhancements through dry runs and receive feedback from lab users, when required.
- Setup verification testing as appropriate for the lab system.
- Assist with User Acceptance Testing for system functionality changes.
- Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
- Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e. visibility to testing queues, testing metrics monitoring, etc) to support product release, new products, and key performance indicators/lean lab 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 on the lab system.
- 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 lab system 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 2 to 4 years' experience.
- Knowledge and in depth understanding of analytical techniques preferred.
- Proficient knowledge of lab systems such as LabVantage LIMS, ELN, SDMS, etc., Understanding of system interfaces and impact of changes to each.
- 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 lab 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 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.
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.
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