Senior Scientist Microbiology Global QC

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US. 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 Global QC Sciences team, we are looking for a highly motivated Senior Scientist Microbiology Global QC. As our team is primarily based in Leiden, the Netherlands, you are ideally based near Leiden.

Scope of the job

As a Senior Scientist Microbiology Global QC, you will be an integral member of the Global QC Sciences team, part of the larger Global QC Cell Therapy Operations department.

We are committed to implementing state-of-the-art automated (rapid) assays tailored to our decentralized model. In this role, you will leverage your knowledge and experience to ensure that QC methods are compliant with quality standards and regulatory frameworks. Your contributions will directly enhance our product release strategy, ultimately enabling more patients to receive treatment. 

Your role

• Improve and implement our robust sterility assurance strategy, conduct thorough assessments, develop comprehensive contamination control and monitoring plans, update SOPs, train staff, validate processes, continuously measure performance, and regularly review and update the strategy.
• Provide scientific expertise for analytical development, in-process control testing, release, stability, tech transfer, comparability, and other collaborative studies with Process Development, Manufacturing, Science & Technologies (MSAT), Analytical Development, Quality Control Operations, and other teams in both the EU and US.
• Oversee the lifecycle of analytical methods, including verification and validation.
• Lead laboratory investigations, including Out of Specification and Out of Trend investigations.
• Manage change controls, conduct impact assessments, and implement Corrective and Preventive Actions.
• Author, review, and provide technical support for regulatory documents, filings, and communications.
• Mentor and coach peers, scientists, and technicians.