Lead QC Microbiologist

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.

What will you do?

We are looking for a Lead QC Microbiologist who is responsible for in-process as well as release testing of cell- and gene therapy products in accordance with the GMP quality systems. The Lead Quality Control authors QC- and project related documentation and is also responsible for the execution of risk assessments. You will closely collaborate with other departments and supervise the Environmental Monitoring Technician(s) and Microbiological/Physicochemical focused Scientist(s) team members.

• Transfer and/or implementation of assays, including development and qualification/validation;

• Contribute to the design of project proposals based on client specifications, planning, resource forecast, and consumable estimates;

• Responsibility for timely delivery of QC tests including planning, design and execution;

• Contribute to release of Cell- and Gene Therapy products for clinical trials;

• Ensure, execute and maintain Environmental Monitoring program for the facility;

• Data analysis and report preparation with critical evaluation of results, identifying improvement opportunities (for example, related to testing, equipment, EM);

• Support incoming material management, including release flow elements, sampling & testing, release of GMP goods;

• Drive QC equipment procurement and qualifications and ensure equipment remains in a controlled status;

• Write, implement, review and maintain policies, SOPs, protocols, sample & test forms and other QC related documentation in alignment with applicable GxP guidelines;

• Drive continuous improvements within QC and alignment with regulations and technical developments;

• Performs deviations-, OOS- investigations, write Change Controls, CAPA’s, Risk Assessments, protocols, plans and reports;

• Train, monitor and coach performance of QC team members;

• Support internal and external Audits as Subject Matter Expert.

Who are you?
As Lead QC Microbiologist you are responsible for the microbiological test strategy including the execution of environmental monitoring, trending of data and reporting. You are the SME for the transfer, development and qualification/verification of assays, which includes in-process as well as release testing of cell- and gene therapy products and relevant materials in accordance with the GMP quality systems.

We are looking for a Lead QC with:

• MSc. or higher degree in a relevant field (biology, microbiology, biotechnology or similar);

• At least 5 years of relevant work experience in a GMP compliant industrial setting;

• Knowledge of GMP requirements for sterile biologics and-assays;

• Experience with Advanced Therapy Medicinal Products will be advantageous;

• Experience with working in quality control and assay development in a biotech environment;

• Experience with varioustechniques, for example microbial (endotoxin, bioburden, rapid sterility, mycoplasma, microbial culturing and species identifications), EP testing, , etc;

• Knowledge about cell based & Molecular assays is a plus,

• Experienced in writing SOP’s and other GMP Documents e.g. test records, qualification / validation documents, specifications etc.;

• Hands on experience with the relevant assays;

• Experience with Data Integrity requirements;

• Strong verbal and written communication skills in English.

What do we offer you?

• A monthly salary between €5,582 and €7,175 (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?
Don't hesitate to contact Diederik Pardon at d.pardon@necstgen.com for more information.