Principal Scientist/Process Engineer Global MSAT (Associate Director), 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’.

For our Cell Therapy organization in Leiden, we are looking for a Principal Scientist/Process Engineer Global MSAT (Associate Director level)

Scope 

We are seeking an Principal Scientist/Process Engineer MSAT to join the team in the Leiden Bio Science Park, The Netherlands. The Principal Scientist/Process Engineer Global MSAT is and experienced engineer who provides technical/scientific leadership and strategic guidance to progress product and process life cycle activities and works in close collaboration with a team of process engineers to drive CAR-T processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Lead authoring of regulatory filings and health authority questions related to Global MSAT related technical and process responsibilities.
• Lead workstreams and provide scientific and technical guidance to the process engineers related to the overall process validation lifecycle, stability and comparability study strategies.
• Lead development and implementation of innovative decentralized manufacturing solutions and offer expertise in troubleshooting related to GMP operations and technology transfers and clinical manufacturing.
• Provide technical expertise and guidance to optimize manufacturing procedures and progress towards commercial readiness of the decentralized CAR-T manufacturing platform.
• Build trust and foster positive relationships with the teams and key CMC, QA and RA stakeholders to create a supportive and collaborative work environment.
• Mentor and guide engineers, fostering a culture of innovation and excellence to identify and implement improvements in the cell therapy processes and procedures, including process/product change controls and automation/digitalization.
• Ensure compliance with relevant quality and regulatory requirements.

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