Are you a QC scientist with a passion for quality and innovation. Do you want to contribute to a innovative and fast growing environment? Then please continue reading!
Who are we?
NecstGen is a leading CDMO (Contract Development and Manufacturing Organization) focused on process development and GMP manufacturing of cell and gene therapies. We are an independent, non-profit organization with a state-of-the-art facility in Leiden, specifically designed to develop, manufacture, and deliver these complex therapies to patients.
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.
Working at NecstGen means:
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
Requirements
What will you do?
As a Quality Control Scientist, you will play a key role in the QC department. You are responsible for developing, executing, and improving analytical QC methods to ensure the quality and safety of our cell and gene therapy products. You will contribute to both the start-up and operational phases of our GMP manufacturing facility.
Your responsibilities include:
Development, transfer, and qualification of microbiological and/or analytical methods (e.g. endotoxin, bioburden, sterility, qPCR, ELISA, flow cytometry, cell-based assays);
Execution of in-process and release testing of products and materials;
Supporting environmental monitoring programs with verifications and reviews;
Writing and maintaining GMP documentation (SOPs, protocols, reports, CAPAs, etc.);
Participating in equipment selection, implementation, and qualification;
Supporting investigations (deviations, OOS), and contributing to continuous improvement initiatives;
Training and mentoring QC technicians when needed;
Representing QC as Subject Matter Expert during audits and inspections.
Who are you?
You are a motivated, detail-oriented scientist with a passion for quality and innovation. You thrive in a dynamic, fast-paced, GMP-regulated environment and enjoy contributing to building new systems and processes.
Your profile:
MSc or BSc in a relevant field (e.g. microbiology, biotechnology, analytical chemistry);
At least 3 years of experience in quality control or assay development in a biotech/pharmaceutical environment;
Hands-on experience with relevant QC techniques and GMP principles;
Familiarity with rapid microbiological methods and environmental monitoring is a plus;
Analytical mindset, organized, and capable of working independently and collaboratively;
Strong communication skills in English (written and verbal);
Flexible, independent and proactive attitude in a scale-up environment.
What do we offer?
At NecstGen, you’ll have the stability of solid working conditions and the dynamic opportunities of a fast-growing scale-up.
A monthly salary between €3,413 and €4,597 (based on a 36-hour workweek);
13th-month salar, paid in November;
A premium-free pension scheme
Opportunities for growth, training, and professional development;
Flat organizational structure with an open, collaborative culture;
A chance to shape the future of cell and gene therapy manufacturing from the ground up.
Questions?
Don’t hesitate to contact Diederik Pardon at [email protected] for more information
