(Senior) Scientist Viral Vector

About the position

We are looking for a (Senior) Scientist Viral Vector who isn't afraid to take on both process development and GMP manufacturing challenges, thriving in an ever-changing startup-like environment. The ideal candidate brings hands-on experience and a sound understanding of both Viral Vector science and their GMP regulations to the table. We are seeking an active participant who is ready to participate in diverse projects, offer solutions, and engage with clients and collaborators.

As a (Senior) Scientist you are responsible for the development and scale-up of selected parts (e.g. USP or DSP) of in-house platform processes (LV, AAV or Ad) as well as development and tech transfer of selected unit operations of client processes. You also directly participate in the GMP manufacturing operations in the cleanroom.

• Hands-on work in the development laboratory and cleanrooms to support process development of Viral Vector products;
• Participation in the GMP manufacturing of Viral Vector products for clinical trials in cleanroom environment;
• Contribution to the design of project proposals based on client specifications, planning, resource forecast, and consumable estimate;
• Writing, implementing, reviewing and maintaining SOPs, policies and other manufacturing related documentation in alignment with applicable GxP guidelines;
• Initiation and supporting deviations investigations, Change Controls, CAPA’s, Risk Assessments, protocols and reports;
• Experimental planning;
• Data analysis and report preparation with critical evaluation of results, identifying weak spots and possible sources of error, suggesting follow-up actions;
• Collaboration with Analytics/QC to support assay development and validation.

Key qualifications
We expect a minimum of 3-5 years of recent immersion in the biopharmaceutical landscape, including a proven track record of process development and/or GMP operations. The role requires understanding of the science and practice of either USP or DSP operations. Should you also possess proficiency in areas such as vector development, assay development, analytics/QC, cell banking, cell line generation or project management, we consider it an additional asset that we would greatly appreciate hearing about.

• PhD or MSc in biomedicine, biochemistry, biotechnology or similar;
• Experience in Viral Vector development and/or manufacturing projects;
• Experience in leading a team of diverse experts;
• Knowledge of GMP standards;
• Hands on experience with the relevant platforms, processes and systems used for Virus Vector Manufacturing;
• Experience with Viral Vector products based on Adenovirus, Adeno-Associated Virus (AAV) or Lentivirus (LV);
• Strong verbal and written communication skills in English.

Offer

It is important that you are 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:

• 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 € 0,23 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+m² 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!

Don’t hesitate to contact Warda Cardozo, Head of HR for more information.

Unfortunately, sponsorships for Non-EU citizens are not available. We do not wish to be approached as a potential customer or client.