As a CAR-T Operations Support Lead, you will coordinate and co-execute support activities necessary for the daily production of personalized cell therapies in a sterile cGMP environment. Your role ensures seamless execution of material transfers, cleanroom maintenance, inventory replenishment, and sterilization processes, while maintaining compliance with cGMP regulations. You will collaborate with multiple departments to optimize operational efficiency and act as the first point of contact for support operators on the production floor.
What can you expect?
Here's what you'll do:
* Act as an SME for quality aspects related to support production activities, ensuring compliance with cGMP regulations.
* Manage documentation review, including SOPs, logbooks, and batch records, ensuring timely approvals.
* Conduct routine and non-routine inspections of documentation and GMP housekeeping in production zones.
* Collaborate with Quality and MS&T to oversee QMS-related processes, including deviations, CAPAs, and change controls.
* Represent support production quality aspects in internal and external audits, acting as a key contact for QA.
* Lead daily support operations, ensuring timely material transfers, sterilization, and waste management in cleanroom environments.
* Optimize support processes to improve efficiency and ensure timely execution of production tasks.
* Oversee inventory management, including replenishment and storage of critical materials.
* Assign daily tasks to support operators and ensure compliance with operational protocols.
* Act as a liaison between logistics and warehouse teams to manage material availability.
* Lead or participate in continuous improvement initiatives related to cleanroom behaviors, equipment maintenance, and environmental monitoring.
* Monitor and report on key performance indicators (KPIs) related to production support.
Who are we looking for?
Education:
* Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or a related field.
Experience:
* 5 - 3 years of operational experience within a GMP or ATMP environment in the biotech/(bio)pharma industry.
* At least 1 year of experience leading teams or managing projects.
Languages:
* Fluent in Dutch and English.
Strengths:
* Strong leadership skills with the ability to influence and communicate effectively.
* Excellent organizational and problem-solving skills.
* Ability to manage multiple tasks, shifting priorities, and strict deadlines in a fast-paced environment.
* Hands-on, can-do attitude with a focus on continuous improvement.
* Strong attention to detail and commitment to compliance.
Expertise:
* Knowledge of cGMP regulations and cleanroom behaviors.
* Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
* Experience with S4/SAP is a plus.
* Ability to work in shifts, including evenings and weekends as required.
* Willingness to accommodate unplanned overtime on short 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.
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.#J-18808-Ljbffr