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Global QC Analytical Scientist
Job description
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 QC Analytical Scientist . As our team is primarily based in Leiden, the Netherlands, you are ideally based near Leiden.
Scope of the job
As a Global QC Analytical 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
- Design and execute method validation and verification.
- Monitor assay performance, including trending.
- Optimization of methods and their documentation.
- Set-up product characterization methods.
- Verify QC results generated in-house and at the decentralized sites.
- Training and coaching of peers and technicians.
- Perform laboratory investigations and OOS/OOT investigations.
- Write procedures, plans, reports, work instructions.
- Provide input for change controls, impact assessments and CAPAs.
Job requirements
Who are you?
- PhD in life sciences with 2+ years’ experience in pharmaceutical industry or Master in life sciences with 5+ years’ experience in pharmaceutical industry, ideally in Cell Therapy.
- A broad knowledge of flow cytometry, cell-based assays and PCR techniques.
- Experience with troubleshooting instruments, methods and unexpected results.
- Knowledge of GMP, ICH guidelines, pharmacopeia and regulatory requirements.
- Strong interpersonal, verbal and written communication skills.
- Ability to be flexible with changing priorities.
- Self-driven and can-do mindset, without compromising quality.
- Fluent in English
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…!