QA Specialist

Are you an enthusiastic QA Specialist?  Do you enjoy working in a scale-up environment? Do you have GMP experience? Are you based in the Leiden area? Then keep reading!

NecstGen is an independent subsidiary of the Leiden University Medical Center (LUMC). Thanks to this independent position, we can fully focus on innovation and accessibility in cell and gene therapy. Our location at the Leiden Bio Science Park, one of Europe’s largest life sciences clusters, offers direct access to a network of experts, partners, and emerging talent.

By investing in advanced manufacturing technologies and strategic collaborations, we support academic institutions, start-ups, and biopharmaceutical companies in scaling up their innovative therapies. Our expertise and flexible approach enable organizations to execute complex manufacturing processes efficiently and according to the highest quality standards.

• Contributing to the future of healthcare with innovative cell and gene therapies.

• Working in a modern, high-tech environment with the latest equipment.

• Being part of a close-knit and motivated team where collaboration and growth are central.

• The opportunity for professional development in a fast-growing sector with many career advancement opportunities.

• Working at a strategic location in the Leiden Bio Science Park, at the heart of an international network of experts and companies.

• MSc in Biotechnology, chemistry, biopharmaceutics or equivalent;

• Proficiency in cGMPs, GDPs and regulations promulgated by the EMA or equivalent regulatory Agencies;

• Three years of recent experience in (bio)pharmaceutical environment with at least one years of recent experience in Quality Assurance;

• Experience within a sterile manufacturing environment, preferable ATMPs (biologicals, vaccines, injectables, parenteral);

• Good communication skills in English (in writing and verbally);

• Willingness to travel: occasional travelling may be required to support the auditing program.