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CAR-T Operations Batch Record Reviewer
Are you passionate about making a significant impact in healthcare? Join us as a CAR-T Operations Batch Record Reviewer 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, including cancer.
Job
In this key position, you uphold the highest quality standards in the production of our cell therapies. Here is what your role involves:
Quality assurance: You rigorously review and verify batch records to ensure accuracy and compliance with cGMP standards.
Documentation coordination: You efficiently manage and update status tracking spreadsheets, prepare detailed reports, and ensure the accuracy and availability of all production documentation, including batch records, labels, and forms.
Process auditing support: You assist in conducting process audits and maintaining compliance with internal audits to uphold our strict quality standards.
Cross-functional collaboration: You work closely with various departments including Manufacturing Operations, Quality Control, and Planning to streamline operations and support batch record execution.
Continuous improvement: You engage in initiatives to enhance batch record cycle times and contribute to projects that aim to improve operational efficiencies and reduce errors.
Profile
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 bring a minimum of one year's experience working 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.
Benefits
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 permanent contract 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.
Company profile
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for hard-to-treat diseases like cancer.
Since our founding in 2014, we have expanded to over 2,000 employees across six global manufacturing facilities, with our headquarters in New Jersey.
In Ghent, we specialize in producing advanced CAR-T therapies for multiple myeloma, in partnership with Johnson & Johnson.
