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

As Senior Process Engineer/Scientist Global MSAT, you join the Cell Therapy Manufacturing Sciences and Technology (MSAT) team, providing technical-scientific expertise to the GMP operations at decentralized manufacturing units in Europe. You are a subject matter expert on the manufacturing process during development of the next generations of automated CAR-T, helping to drive processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Act as subject matter expert on the automated CAR-T manufacturing process and technology transfers and clinical manufacturing in a decentralized manufacturing model.
• 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 the implementation of product/process related change controls in the global network.
• Support Life Cycle Process Validation activities through the stages of process design, process qualification and continued process verification, as well as process and product comparability.
• Support initiatives for real time process/product monitoring, manufacturing equipment lifecycle & reliability.
• Review and 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.