Operations Project Expert

**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.

As an **Operations Project Exper**t, you will be an integral part of the Operations Project team, driving projects that support the manufacturing operations of our CAR-T manufacturing plant. Your role will ensure the timely readiness of clinical and commercial CAR-T product supply for both Europe and the US. By coordinating multidisciplinary teams, you will manage low-impact projects within a sterile cGMP/ATMP environment, focusing on process optimization, cost reduction, and compliance with quality and safety standards. You will collaborate with various departments, ensuring seamless project execution and alignment with strategic goals. The Operations Project Expert will report to the Operations Senior Advanced Project Supervisor.

**What can you expect?**

**Here's what you'll do**:

- Act as an Operational PMO for low-impact projects related to manufacturing operations, QMS (investigations/CAPA/doc updates), IT systems, Training, EHS, and material management.
- Support the design and implementation of facility, equipment, and systems from an operational and business perspective.
- Contribute to Technology Transfer milestones, ensuring operational readiness, execution of Aseptic Process Simulations, Engineering, Stability, and Process Validation runs.
- Develop a robust operational documentation framework, including SOPs, batch records, and work instructions, and oversee training implementation.
- Support audit readiness by performing gap assessments and executing corrective actions.
- Define interdependent project deliverables and ensure timely execution within approved timelines.
- Provide project risk mitigation solutions and guidance to operational management.
- Prepare and manage governance interactions and stakeholder communication plans.
- Monitor and report on project progress, KPIs, and ensure alignment with strategic goals.

**Who are we looking for?**

**Education**:

- A Master's degree in Science, Biotechnology, (bio)-Engineering, Biomedical, Pharmacy, or equivalent education/experience.
- Alternatively, a Bachelor's degree in (bio)-Engineering, Science, Pharmacy, or related field with 1.5 years of experience in Operations or within a cGMP/ATMP environment.

**Experience**: Prior experience in manufacturing, quality, or engineering is preferred.

**Languages**: Proficiency in English is required; Dutch is an advantage.

**Strengths**:

- Strong leadership, teamwork, and relationship-building skills.
- Ability to manage multiple projects, prioritize effectively, and integrate cross-functional issues.
- Excellent organizational, analytical, and problem-solving skills.
- Hands-on, can-do attitude with a focus on continuous improvement.
- Strong attention to detail and ability to work in a fast-paced, dynamic environment.

**Expertise**:

- Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
- Experience in technology transfers, QMS processes, and production documentation management.
- Strong stakeholder communication and project coordination skills.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

**What do we offer you?**
- A **meaningful job**with an **excellent work-life balance**.
- A **supportive and innovative work environment.**We value and encourage learning and personal development.
- The opportunity to **work with people from all over the world**.
- A contract of indefinite duration and **an attractive salary package**complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
- Many **fun and informal events**.

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Legend Biotech maintains a drug-free workplace.