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.
