Be: Operations Investigations Supervisor

**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 Senior Advanced Investigations Supervisor, you will play a critical role in supporting the manufacturing operations of our CAR-T manufacturing plant. Your leadership will ensure the successful execution of investigations and related projects, directly impacting the readiness of clinical and commercial CAR-T product supply in both Europe and the US. By managing and coordinating multidisciplinary teams, you will contribute to continuous improvement, compliance, and operational excellence.

**What can you expect?**

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

- Lead and manage one or multiple operational investigation (sub)teams and associated projects to support manufacturing operations in an aseptic cGMP production environment.
- Ensure business continuity for clinical and commercial batches per the yearly manufacturing plan.
- Develop the investigation/deviation strategy with MS&T and QA for batch and non-batch-related investigations and CAPAs.
- Drive initiatives to reduce turn-around time for closing investigations and CAPAs.
- Oversee and align investigation subteams (Obelisc and Techlane) in terms of standardization, expertise, roles, and responsibilities.
- Act as the key contact for high-impact operational continuous improvement projects related to investigations/CAPAs in alignment with strategic company initiatives.
- Ensure compliance with quality and safety standards while fostering a high-performance team environment.
- Support audit readiness by performing NC/CAPA reviews and executing/supporting associated actions.
- Develop risk mitigation solutions and provide guidance to operational management.

**Who are we looking for?**

**Education**: A Master's degree in Science, Biotechnology, (bio)-Engineering, Biomedical, Pharmacy, or equivalent education/experience.

**Experience**:

- Minimum of 7 years of experience within Operations or in a cGMP/ATMP environment in the biotech/biopharma industry.
- Prior experience in manufacturing and/or quality is required.

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

**Strengths**:

- Strong leadership, teamwork, and interpersonal skills.
- Ability to manage multiple tasks, integrate cross-functional issues, and balance competing priorities.
- Strong analytical, problem-solving, and critical-thinking skills.
- Continuous improvement mindset with a can-do attitude and hands-on approach.
- Ability to work in a fast-paced, dynamic environment while maintaining attention to detail and compliance.

**Expertise**:

- Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
- Experience in investigation handling, deviation management, and CAPA processes.
- Strong communication and stakeholder management skills across departments.
- 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.