Car-t Investigator

il y a 3 semaines

Gent, Belgique Legend Biotech EU Temps plein

**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.

**Investigator**

At Legend Biotech, we are pushing boundaries in cell and gene therapy to transform patients' lives. As an **investigator**, you will be at the forefront of ensuring the quality, efficiency, and compliance of our innovative therapies. If solving complex challenges and driving innovation excites you, this is your chance to make an impact.

**What you will do**

As an investigator at Legend Biotech, your role will be dynamic and impactful. Key responsibilities include:

- **Leading investigations**:You conduct thorough analyses of production deviations and incidents, identify root causes, and implement effective corrective and preventive actions (CAPAs) to ensure product safety and timely releases.
- **Ensure quality and compliance**: You uphold the highest GMP standards by maintaining regulatory compliance, proactively addressing risks, and driving quality enhancements.
- **Represent during inspections**: You act as a regulatory contact, confidently presenting investigation strategies and effectively responding to observations during audits and inspections.
- **Drive continuous improvement**: You identify trends, share lessons learned, and optimize processes to enhance efficiency while preventing recurring issues.
- **Collaborate across teams**: You work closely with multidisciplinary departments, including production, quality control, and engineering, to ensure seamless knowledge transfer and successful project execution.

**What you bring**

**Education**: You hold a master's degree in (bio)engineering, science, pharmacy, or a related field, or possess equivalent practical experience.

**Experience**: You have at least 3 years of professional experience in a cGMP or ATMP environment, ideally within the biotech or biopharma industry.

Previous experience in manufacturing, quality, engineering or cell and gene therapy is essential.

**Languages**: You are fluent in English, ensuring smooth communication in a diverse and global workplace.

**Strengths**:

- You are team-oriented with excellent organizational and problem-solving skills.
- You bring a proactive, results-driven mindset paired with strong analytical skills to tackle challenges effectively.

**Expertise**:

- You have extensive knowledge of cGMP regulations and FDA/EU guidance related to ATMPs (Advanced Therapy Medicinal Products).
- You have experience with risk assessment and root cause analysis.

**What we offer**
- **Meaningful impact**: Contribute to life-saving treatments and work in a purpose-driven organization where your efforts make a difference for patients worldwide.
- **Global collaboration**: Partner with diverse teams and leading experts across the globe to drive breakthroughs.
- **Professional growth**: Access training programs, industry conferences, and opportunities for career advancement.
- **Comprehensive benefits**: Enjoy a permanent contract, competitive salary, extra vacation days, meal vouchers, and extensive insurance coverage.
- **Supportive culture**: Thrive in a workplace that values teamwork, innovation, and personal development.

**About Legend Biotech**

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and delivering groundbreaking cell therapies that tackle some of the most chronic and life-threatening diseases, like cancer.

Founded in 2014 and headquartered in Somerset, New Jersey, Legend Biotech employs over 2,500 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).
In Ghent, our dedicated teams specialize in producing cutting-edge CAR-T cell therapies for the treatment of multiple myeloma, working closely with Johnson & Johnson to transform patient outcomes.

LI-AG1

Legend Biotech maintains a drug-free workplace.

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