Global Senior QC Microbiology Scientist

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 Global Senior QC Microbiology Scientist . As our team is primarily based in Leiden, the Netherlands, you are ideally based near Leiden.

Scope of the job

As our Global Senior QC Microbiology Scientist, you will be an integral member of the Global QC Sciences team, part of the larger Global QC Cell Therapy Operations department. The Global QC Sciences team provides strategic direction and manages the lifecycle of analytical methods, material quality, support for tech transfers to Galapagos’ decentralized sites, and sterility assurance. Our expertise encompasses both bioanalytical and microbiological domains, utilizing techniques such as flow cytometry, PCR, immunological assays, luminescence, and microscopy.

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 PD, MSAT, AD, QC Operations, and QC 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.

Who are you?

• PhD in life sciences with 5+ years of experience in the pharmaceutical industry.
• Broad knowledge of latest rapid microbial detection techniques.
• Demonstrated competence for investigating unexpected results.
• Proficiency in applying ICH Quality Guidelines, cGMPs, EP/USP for cell therapies, and Annex 1.
• Demonstrated competence for authoring risk assessments, company positions and justifications.
• Demonstrated competence for authoring, reviewing, and providing technical support for regulatory filings, including multiple clinical trial applications (IND/IMPD) and ideally at least one marketing authorization (BLA/MAA).
• Strong interpersonal communication skills. Flexible with changing priorities. Resilient.
• Ability to engage and motivate peers, scientists, and technicians.

What’s in it for you?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

We are Galapagos: together we make it happen...!