QC Lead (Analytical)

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 Europes 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.

What will you do

We are looking for a Lead QC Analytical Scientist who will be responsible for in-process and release testing of cell- and gene therapy products in accordance with GMP quality systems. The Lead QC Analytical authors QC- and project-related documentation and is responsible for the execution of analytical method lifecycle activities and risk assessments. You will collaborate closely with other departments and supervise Analytical-focused Scientist(s) and Technician(s) within the QC team.

• Lead the transfer development qualification and validation of analytical assays (e.g. potency purity identity and safety testing) to support product release and stability programs;

• Contribute to the design of project proposals based on client specifications including planning resource forecasting and consumable estimation;

• Ensure timely delivery of QC analytical testing including planning execution and review of data;

• Support the release of Cell- and Gene Therapy products for clinical trials through accurate data review and evaluation;

• Perform data analysis trending and critical interpretation of analytical results identifying improvement opportunities and supporting troubleshooting;

• Oversee QC equipment procurement qualification calibration and maintenance to ensure systems remain in a controlled state;

• Support incoming material management including sampling testing and release of GMP materials;

• Write implement review and maintain policies SOPs protocols test methods and other QC documentation in compliance with GxP guidelines;

• Drive continuous improvement initiatives within the analytical QC function ensuring alignment with regulatory expectations and technical advancements;

• Perform and review deviations OOS/OOT investigations Change Controls CAPAs Risk Assessments and validation documents;

• Train mentor and support QC team members in analytical methods and GMP compliance;

• Act as a Subject Matter Expert (SME) during internal and external audits and client inspections.

Who are you

As Lead QC Analytical you are responsible for the analytical testing strategy including the development qualification and validation of methods that ensure the quality and consistency of NecstGens cell- and gene therapy products. You act as Subject Matter Expert for analytical assays used for in-process control release and stability testing and provide technical leadership to the QC team.

We are looking for a Lead QC with:

• MSc. or higher degree in a relevant field (e.g. biochemistry molecular biology biotechnology analytical chemistry or similar);

• At least 5 years of relevant work experience in a GMP-compliant biopharmaceutical or biotechnology environment;

• Strong understanding of GMP requirements for biological and analytical testing;

• Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage;

• Proven experience in analytical method development transfer and validation;

• Hands-on experience with cell-based assays molecular assays (qPCR ddPCR) and/or physicochemical techniques (ELISA HPLC flow cytometry spectrophotometry);

• Experience in writing SOPs and other GMP documentation such as test methods protocols validation reports and specifications;

• Good understanding of data integrity principles and electronic data systems;

• Strong analytical mindset with the ability to interpret complex data and propose solutions;

• Excellent communication skills in English both written and verbal;

• A proactive and collaborative attitude with a drive for continuous improvement.

What do we offer you

• A monthly salary between 5582- and 6394- (based on a 36-hour workweek);

• A 13th-month bonus paid in November;

• 26 vacation days for a full-time (36-hour) position;

• A premium-free pension scheme;

• Travel allowance for commuting (from 10 km) of 0.23 per km and full reimbursement of public transport costs;

• Various flexible employment benefits in addition to the above.

Questions

Dont hesitate to contact Diederik Pardon at for more information.