Are you an expert in the transfer, development and qualification/validation of assays with the emphasize on microbiological testing and are you looking for an innovative and inspiring working environment where you can make a difference? This is the right opportunity for you!

As Senior Scientist Quality Control you are responsible for the microbiological test strategy including 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.

What you will do

We are looking for a Senior Scientist Quality Control 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 Senior Scientist 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 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.

What we ask
We are looking for a Senior Scientist Quality Control 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 various test techniques, for example microbial (endotoxin, bioburden, sterility, mycoplasma), EP testing, microbial culturing, , cell based assays, etc;
• 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.
  

Offer

It is important that you feel comfortable at work and enjoy coming to the office. We offer a modern and inspiring working environment with a collegial atmosphere, a flat organization with short lines and good employment conditions. You will join the team at an early stage, giving you the unique opportunity to co-define the company and contribute to the NecstGen’s establishment.

• A competitive salary
• 8% holiday allowance
• Permanent 13 th month
• 25 holidays with a fulltime employment of 36 hours per week
• Commuting allowance (from 10 km) of € 0.21 per km and public transport is fully reimbursed
• A non-contributory pension scheme
• Several flexible employment conditions on top of the above conditions
• Exciting dynamics of a scale-up environment and GMP training by our expert team

About NecstGen

Together with our clients and partners we challenge today’s possibilities and enable the unthinkable. NecstGen primarily works with early-stage research organisations, start-ups, and SMEs to develop efficient processes and perform GMP manufacturing for cell and gene therapies. We engage openly with organisations worldwide! NecstGen is a subsidiary corporation of the Leiden University Medical Center. Our unique company formation enables us to be a mission based CDMO and Centre of Excellence. NecstGen’s 4,000+m 2 facility comprises of 13 cleanrooms plus development and Quality Control laboratories for the generation of novel therapeutics. Our team of 40 consists of professionals from industry and academia with an entrepreneurial mindset and a drive to make a difference. We have a flat organisational structure with a participative management style.
Visit our LinkedIn company page to learn more about our team and the latest developments.

We would love to hear from you!

If this position gets you excited, we would love to hear from you! Don’t hesitate to contact Warda Cardozo, Head of HR, at w.cardozo@necstgen.com for more information.

We do not wish to be approached as a potential customer or client.

Unfortunately, sponsorships for Non-EU citizens are not available.