CAR-T Operations Batch Record Reviewer

☞ Legend Biotech

View: 104

Update day: 22-11-2025

Location: Ghent East Flanders

Category: Sales

Industry: Biotechnology Research

Position: Entry level

Job type: Contract

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Job content

Do you have an analytical mindset, a keen eye for detail, and a strong understanding of pharmaceutical processes? If so, the CAR-T Operations Batch Record Reviewer role could be the perfect fit for you! In this crucial position, you’ll play a key role in ensuring the quality and compliance of batch documentation—directly contributing to the success of life-changing CAR-T therapies.

What can you expect?

  • Checking the completeness of all associated documentation, ensuring compliance with written policies and procedures as required for batch release.
  • Performing First Quality review within Operations for executed batch records daily.
  • Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
  • Assisting in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on a daily basis.
  • Assisting in process audits and internal audits as needed.
  • Working closely with QA functional teams to align and promote awareness of data integrity and good documentation practices.
  • Navigating through various online platforms, including MES, SAP, COMET, and eLIMS.
  • Routinely interacting with other departments to collect batch record information or work to resolve documentation issues.

Who are we looking for?

Education:

  • Bachelor’s degree in Science, Bio-Engineering, Pharmacy, or related field, or equivalent experience required.

Experience:

  • An experience within a cGMP or ATMP environment in the biotech/biopharma industry is preferred.
  • Knowledge of GMP is preferred.

Capabilities, Knowledge, and Skills:

  • Ability to accommodate shift work, including weekends as required by the process.
  • Good written and oral communication skills. You’re a team player, willing to share knowledge with new colleagues.
  • Must be proficient in the MS Office Suite and able to coordinate multiple tasks efficiently and willing to learn new software systems such as SAP and MES.
  • Ability to work independently after training and set priorities when having to manage multiple tasks.
  • Can-do attitude, Right first time, and hands-on approach.
  • Tenacity to drive issues until resolved and deliver results.
  • Flexible mindset capable of dealing with ambiguity and responding quickly, energetically, and enthusiastically to changes.
  • Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
  • Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
  • Proficiency with MES/EBR is a nice to have, on the job training will be provided.

Language(s):

  • Fluent English is a must have. Fluent Dutch is a nice to have.

What do we offer you?

  • A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off.
  • 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 for the treatment of chronic and life-threatening diseases, such as cancer.

The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).

In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

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Deadline: 06-01-2026

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