As an Operations Advanced Support Supervisor, you will lead and supervise the support operations team responsible for all production support activities (e.g., Grade B cleaning, Material Transfer, Replenishment, Sterilization) and oversee aspects of the CAR-T process operations (Cryopreservation). Your leadership will ensure safe and compliant manufacturing operations according to cGMP requirements, supporting both clinical and commercial CAR-T production. You will collaborate with various internal stakeholders to address production challenges and maintain seamless execution of daily production tasks.
What can you expect?
Here's what you'll do:
- Act as SME for quality aspects related to production activities, ensuring compliance with cGMP regulations and documentation requirements.
- Manage and review documentation in Production zones, including batch records, work instructions, SOPs, and quality-related records.
- Lead and coordinate production support activities, optimizing schedules for efficiency and compliance.
- Support Tech Transfer plans for new production introductions and process optimizations.
- Contribute to the development of manufacturing processes, training, and continuous improvement initiatives.
- Supervise and coordinate personnel, assigning daily production tasks and ensuring operational readiness.
- Implement and lead Tier 1 and Tier 2 meetings to ensure clear communication and task execution.
- Support internal and external audit readiness, representing Support Production in quality matters.
- Ensure safe and compliant operations according to EHS and cGMP standards.
Who are we looking for?
Education:
- Bachelor's or Master's degree in Science, Bio-Engineering, Pharmacy, or a related field.
Experience:
- Minimum of 1 year in a cGMP or ATMP environment in the biotech/biopharma industry.
- Minimum of 5 years of direct people management experience overseeing teams of 10+ individuals.
Languages:
- Fluent in English and Dutch.
Strengths:
- Strong leadership skills with the ability to manage and motivate large teams.
- Excellent verbal and written communication skills with a structured and direct approach.
- Ability to manage multiple tasks, prioritize effectively, and integrate cross-functional issues.
- Hands-on, can-do attitude with a focus on continuous improvement.
- High attention to detail and ability to adapt in a fast-paced environment.
Expertise:
- Knowledge of cGMP regulations and EMEA guidance related to cell-based manufacturing.
- Experience with Operational Excellence and/or Lean Manufacturing is an asset.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook); MES/EBR knowledge is a plus.
- Ability to accommodate shift work, including evenings and weekends as required.
- Ability to accommodate unplanned overtime with little to no prior notice.
What do we offer you?
- A meaningful job with an excellent work-life balance. You will work 4 days, followed by 4 days off.
- A supportive and innovative work environment that encourages learning and personal development.
- The opportunity to work with people from all over the world.
- A permanent contract and an attractive salary package with numerous benefits, including additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, and performance bonuses.
- Participation in various 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, including two in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde). In Ghent, we focus on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.
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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.