Senior Process Engineer/Scientist Global MSAT, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

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’.

We are looking for a Senior Process Engineer/Scientist Global MSAT 

Scope of the job

We are seeking a Senior Process Engineer/Scientist Global MSAT to join the team in the Leiden Bio Science Park, The Netherlands. The Senior Process Engineer is an experienced subject matter expert on automated CAR-T manufacturing processes and life cycle process validation requirements to progress the development of the CAR-T manufacturing processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Act as experienced subject matter expert on the automated CAR-T manufacturing process.
• 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 and stability.
• Lead the design, execution and analysis of process characterization experiments to progress the process pivotal and commercial readiness.
• Contribute the criticality analysis and development of the manufacturing process control strategy.
• 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.
• Contributes to the implementation of product/process related change controls in the global network (e.g. updates of the electronic batch records, procedures or trainings).
• Support initiatives for real time process/product monitoring, manufacturing equipment lifecycle & reliability.
• Contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module.

The Senior Process Engineer/Scientist reports to the Associate Director Global MSAT.

• 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, process validation and/or process development. 
• 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?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen…!