Legend Biotech - Franklin Township, NJ

posted about 2 months ago

Full-time - Senior
Franklin Township, NJ
Professional, Scientific, and Technical Services

About the position

The Head of Pipeline Systems IT at Legend Biotech will lead the direction of IT systems supporting research and development, early drug discovery, clinical operations, and technical development. This role is crucial for ensuring the quality and efficiency of IT projects and deployments, as well as driving solutions for enterprise IT system demands. The position involves managing the implementation of new IT systems, collaborating with global IT teams, and providing support for compliance and regulatory inspections.

Responsibilities

  • Manage 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.
  • 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/liase 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 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.
  • Act as the first point of contact for business partners.

Requirements

  • Minimum 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.
  • 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.
  • 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.

Nice-to-haves

  • Knowledge of enterprise manufacturing, lab systems and Quality Management concepts that are used in Bio Pharma industry.

Benefits

  • Competitive salary range of $126K - $160K per year.
  • Opportunities for professional development and training.
  • Collaborative and inclusive work environment.
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