3 Senior Process Engineers MSAT - Contractor (6 months), Leiden

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 are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

For our Cell Therapy organization in Leiden, we are looking for 3 Senior Process Engineers Global MSAT.

Scope of the job

We are seeking a Senior Process Engineer 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 technology transfers in a decentralized manufacturing model. The Senior Process Engineer defines plans and procedures to transfer the process globally and 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 and technology transfers and clinical manufacturing in a decentralized manufacturing model.
• 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.
• 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.
• Contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module.