CAR-T Operations Expert

Legendcareerseu; Oost-Vlaanderen; Sur place; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Excellent work-life balance

Additional statutory vacations

Meal vouchers

Double vacation pay

End-of-year and performance bonuses

Bicycle lease plan

Fun and informal events

Résumé du poste

Legendcareerseu in Ghent seeks a CAR-T Operations Expert to lead CAR-T production processes and ensure compliance with industry standards.

The ideal candidate will have a relevant degree, strong communication skills in Dutch or English, and at least five years of operational experience in the biotech or pharmaceutical sector. Work in a supportive environment with a 4-day workweek and excellent benefits.

Qualifications

• At least five years of operational experience with cell culture, preferably in biotech or pharmaceutical industry.
• Thorough knowledge of cGMP regulations and cell culture techniques.
• Strong oral and written communication skills in Dutch or English.

Responsabilités

• Participate and oversee CAR-T manufacturing process activities.
• Ensure compliance with cGMP and GDP standards.
• Manage daily production planning and support production surveys.
• Work with teams to streamline and optimize processes.
• Train and coach junior colleagues.

Connaissances

Operational experience with cell culture

Detail-oriented

Strong relational skills

Analytical and problem-solving skills

Fluent in Dutch or English

Formation

Bachelor's or master's degree in sciences or related field

Outils

Microsoft Office

PASx

eLIMs

Siemens

SAP

Description du poste

We are looking for a passionate CAR-T Operations Expert to join our team in Ghent. Ready to make a difference in patients' lives and lead innovative CAR-T cell therapy projects? Let us hear from you. We'd love to meet you!

What Can You Expect?

As a CAR-T Operations Expert, you will be a specialist in specific parts of the CAR-T production process. Here’s what you’ll do:

• Perform and oversee CAR-T process activities: You will participate in and oversee specific parts of the CAR-T manufacturing process such as component preparation, CAR-T processing, filling and finishing, and cryopreservation.
• Compliance and documentation: You ensure that all activities comply with cGMP and GDP standards. You will develop and maintain GMP documents to ensure compliance and traceability.
• Operational support: You manage daily production planning and support production surveys. You will create and review operational procedures, including work instructions, master batch records and forms.
• Collaborate and continuously improve: You will work with various teams to streamline and optimize processes. You will also participate in Lean & Operational Excellence projects.
• Training: You will train and coach junior colleagues.
• Technology and Systems: You will support the testing and implementation of various software for production output systems such as eLiMS, MES and SAP.

Who Are We Looking For?

Education:

• You have a bachelor's or master's degree in sciences, (bio)engineering, biotechnology, pharmacy or a related field of study, or you are equivalent through experience.

Experience:

• You have at least five years of operational experience with cell culture, preferably in the biotech or pharmaceutical industry. Previous experience in manufacturing, quality or engineering is required.

Languages:

• You are fluent in Dutch or English, with strong oral and written communication skills.

Strengths:

• You are a true team player with strong relational, analytical and problem-solving skills. You are detail-oriented and strive for excellence. You are also motivated and enthusiastic, but it is your "can-do" mentality that typifies you the most.

Expertise:

• You have a thorough knowledge of cGMP regulations and cell culture techniques.
• You can work fluently with Microsoft Office tools such as Word, Excel, PowerPoint and Outlook.
• Experience with cGMP systems such as PASx, eLIMs, Siemens and SAP is a nice plus.

What Do We Offer?

• A meaningful job that contributes directly to the well-being of patients.
• An excellent work-life balance. You work 4 days. Then you 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.
• The possibility to participate in our bicycle lease plan.

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.