Associate Director, IT Cell Therapy for Technical Operations (Ghent, Belgium)

Conteúdo do emprego

Legend Biotech is seeking an Associate Director, IT Cell Therapy for Technical Operations as part of the IT team based in Ghent, Belgium.

Company Introduction

From the very beginning, we’ve been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients’ bear and the difficulties they face, which drove us to think about what’s next.

We believe it’s time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we’re using that hope to ignite the future of CAR-T cell therapy.

Strategic Collaboration

Legend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Role Overview

The Associate Director IT Cell Therapy will be responsible for delivering and supporting IT capabilities used in Technical Operations (manufacturing, supply chain, procurement and etc.).

Major Responsibilities

• Manage business expectations and relationships between IT and Technical Operations
• Proactively understand business priorities, provide inputs to business strategies
• Execute the TechOps IT strategy, roadmap and portfolio based on business priorities
• Implement the delivery of IT portfolios and projects by following security/architecture standards, SDLC and regulatory requirements
• Collaborate with business counterparts to understand and document requirements. Meet with vendors to vet their solutions against business and IT requirements
• Ensure IT capabilities delivered meet functional, performance and value expectations
• Oversee support of installed IT solutions for Technical Operations though Legend internal and outsourced resources, within project schedules and budgets
• Fulfill system administrator duties of key IT solutions for Technical Operations
• Participate in audits and inspections to provide accurate representation of Legend IT systems at the Somerset site
• Participate in QMS workflows supporting Legend IT systems for Technical Operations (change management, deviation management, etc.)
• Align with global application, data and security standards

Requirements

• A minimum of a Bachelor’s Degree in a relevant discipline such as IT or Engineering, advanced degree is preferred
• A minimum 10 year’s relevant working experience in biotech and/or pharmaceutical industries
• Knowledge of TechOps processes (manufacturing, supply chain, procurement)
• Experience in implementing and supporting systems used for GMP manufacturing (such as MES, Data Historian, LIMS, Data Archival, secure file shares)
• Knowledge and experience in manufacturing IT system integrations, such as MES with ERP
• Knowledge of information system development methodologies, including requirements gathering, risk assessments, specification and validation process
• Ability to influence stakeholders and set appropriate expectations for project execution and support initiatives
• Experience with IT strategy and network designs including S95, firewalls and architecture
• Knowledge of cell therapy specific needs in manufacturing is a plus
• Lead a matrixed team for project execution and delivery
• Review contracts with vendors and service providers
• Project management knowledge and skills, including agile methodology
• Excellent written and verbal communication skills
• Ability to perform in a fast-paced working environment

Language Requirement

• Fluent in English