Senior Process Engineer MSAT Consultant

Find your purpose

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.

For our Cell Therapy organization in Leiden, we are looking for a Senior Process Engineer MSAT to join our Global MSAT, Manufacturing Support team for a period of 6 months as a consultant.

Your mission

• Act as experienced subject matter expert on the automated CAR-T manufacturing process and technology transfers and clinical manufacturing in a decentralized manufacturing model
• Lead the implementation of product/process related change controls in the global network
• Lead product/process investigations and define corrective/preventive actions
• Author process descriptions and generate relevant SOPs, Work Instructions and trainings to guide the decentralized manufacturing process in the global network of manufacturing sites
• Contribute to the development of electronic batch records, procedures and trainings for the manufacturing process
• Support initiatives for real time process/product monitoring, manufacturing equipment lifecycle & reliability
• Define plans to ensure progress in the Life Cycle Process Validation activities through the stages of process design, process qualification and continued process verification, as well as process and product comparability
• Contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module

In this role, your manager would be our Associate Director Global MSAT.

Who are you?

• PhD degree in life sciences, biotechnology, engineering or related discipline with at least 7 years’ work experience or MSc with an equivalent level of experience
• Demonstrated experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer and process validation
• Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies
• Knowledge of data management tools and statistical process controls is a plus
• Result-driven and can-do mindset, without compromising quality and compliance
• Responsibility for own projects while pursuing company goals in open collaboration. Ability to be flexible with changing priorities
• Good interpersonal skills and written and spoken fluency in English

What's in it for you?

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.

We are Galapagos: together we can make it happen!

We’re in the business of changing lives. In our quest to discover, develop and deliver life-improving medicines, we go where no one has ever gone before.