Car-t Operations Batch Record Coordinator
il y a 1 semaine
**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.
**CAR-T Operations Batch Record Coordinator**
Are you passionate about making a significant impact in healthcare? Join us as a CAR-T Operations Batch Record Coordinator and embark on a career where your expertise is pivotal in producing personalized cell therapies aimed at treating some of the most life-threatening and challenging diseases, like cancer.
**What can you expect?**
In this key position, you uphold the highest quality standards in the production of our cell therapies. Here is what your role involves:
- **Team coordination**: You ensure a seamless workflow by assigning Batch Records to the right reviewers, resolving issues, and fostering team success.
- **Team planning**: You support supervisors in planning and scheduling, keeping the team aligned and productive.
- **Quality assurance**: You meticulously review and verify batch records to maintain accuracy and full compliance with cGMP standards.
- **Documentation management**:You keep status tracking spreadsheets up-to-date, prepare detailed reports, and ensure all production documentation—batch records, labels, and forms—is accurate and readily available.
- **Process auditing**: You assist in process audits and ensure compliance with internal quality standards to uphold our rigorous benchmarks.
- **Cross-functional collaboration**: you partner with departments like Manufacturing Operations, Quality Control, and Planning to streamline processes and support efficient batch record execution.
**Who are we looking for?**
**Education**:
You have a bachelor's or master's degree in science, bioengineering, pharmacy or a related field of study or you are equivalent through experience.
**Experience**:
You have at least three years of experience in a cGMP or ATMP environment, ideally within the biotechnology or biopharmaceutical industry.
**Languages**:
You are fluent in Dutch and English.
**Strengths**:
You possess excellent communication and organizational skills, allowing you to manage projects efficiently and effectively. Your ability to work independently helps you handle multiple tasks simultaneously without compromising quality. Additionally, your strong analytical and problem-solving skills effectively resolve challenges.
**Expertise**:
You are proficient in MS Office and eager to master industry-specific software such as MES, SAP, and eLIMs. Your experience with electronic batch record systems is a significant asset.
**What do we offer you?**
- A **meaningful job**with an **excellent work-life balance,**while working in a 4 days work 4 days off shift regime.
- 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**.
**About Legend Biotech**
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for intractable diseases such as cancer.
Since our founding in 2014 in Somerset, New Jersey, we have grown into a company with more than 2,000 employees in six manufacturing facilities worldwide.
In Ghent, we are focusing on the production of our advanced CAR-T therapy for the treatment of multiple myeloma, in collaboration with Johnson & Johnson.
Legend Biotech maintains a drug-free workplace.
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