Associate Director, Lab and GxP R&D IT Solutions Lead

Legend Biotech is seeking an Associate Director, Lab and GxP R&D IT Solutions Lead as part of the IT team based in Somerset, NJ.

Role Overview

The Lead of Lab Computing and GxP Research & Development Solutions will be responsible for all GxP Regulated IT systems in the Exploratory Technology, Early Drug Discovery, and Technical Development business units. In addition, this role will manage, maintain, and assist in the operation of IT capabilities in all the R&D labs in the US Legend sites. He/she will implement, support, and retire IT capabilities in R&D.

Key Responsibilities

• Product Owner of GxP systems in Exploratory Technology, Early Drug Discovery, and Technical Development business units
• 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.
• Collaborate/liase with appropriate site/global IT teams to ensure needs and requirements are accurate in the pipeline 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.
• 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 systems.
• Provide ad-hoc support to users for issues/questions on the lab systems.
• 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.
• Provide support to the lab computing (benchtop) environment.
• Deploy or update data management tools for backup and archive.
• Evaluate solutions to manage the data collected from instrument systems are stored and can support data analytics initiatives.
• Manage a team of employee(s) and contractor(s) that provides support to the business function.

Requirements

• Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 10 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 is 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 technically 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.

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