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.
Role Overview
The IT Business Partner will be responsible for partnering with business stakeholders for the identification, implementation, maintenance and continuous improvement of IT solutions to support Legend Biotech Belgium (Technical Operations) and ensure compliance with relevant regulations.
Major Responsibilities
* The BP is responsible for understanding business objectives and requirements and for developing the technology strategy needed to support the business (together with the IT BP Director).
* This role facilitates the prioritization of technology projects.
* The BP owns the technology portfolio. This includes delivery, support & budget management. This role is accountable for ensuring that this portfolio follows appropriate IT standards (such as Global Security policies and procedures).
* The Business Partner is the “Product Manager” for the applications that support the function(s) and owns the lifecycle management plan for these applications.
* Own software selection process for new IT solutions. Meet with vendors to vet their solutions against business and IT requirements. Ensure IT capabilities delivered meet functional, performance and value expectations.
* Participate in audits and inspections to provide accurate representation of Legend IT systems at the Ghent sites.
* Participate in QMS workflows supporting Legend IT systems (change management, deviation management, etc.).
* Collaborate directly with the business clients, IT Business Partners and other IT functions on delivery of digital capabilities.
* Act as trusted advisor for infrastructure technology.
Education
Minimum of a Bachelor’s Degree in a relevant discipline such as IT or Engineering is required; advanced degree is preferred.
Experience
* Minimum 5 years relevant working experience in biotech and/or pharmaceutical industries.
* Experience or knowledge of IT systems used to support Supply Chain Management, Quality, Manufacturing, Engineering & EHS.
* Experience in implementing and supporting systems used for GMP manufacturing (such as SAP, MES, Data Historian, LIMS).
* Experience of working in a regulated environment. Working knowledge of Good Manufacturing Practices (GMP), Data Integrity and Computers Systems Validation (CSV) is required. Prior experience with GMP and CSV within the pharmaceutical industry is required.
Capabilities, Knowledge, and Skills
* Knowledge of TechOps processes (manufacturing, supply chain, procurement, quality, warehousing).
* Knowledge of cell therapy specific needs in manufacturing is a plus.
* Management skills and understanding of project management lifecycle.
* IT system lifecycle knowledge to include requirements gathering, change management, implementation and continuous support.
* Review contracts with vendors and service providers.
* Excellent written and verbal communication skills.
* Ability to perform in a fast-paced working environment.
Language(s):
* Fluent in Dutch and English.
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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