Lead Scientist Viral Vector

About the position

We're looking for a seasoned Lead 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 a wealth of 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 independently drive projects, offer solutions, and engage with clients and collaborators.

As Lead Scientist you are responsible for the development and scale-up of selected in-house platform processes (LV, AAV or Ad) as well as development and tech transfer of client processes. You are independently liaising with the clients, mentoring scientists and specialists and advising the Head of Viral Vector. The role of Lead Scientist Viral Vector includes both scientific and administrative tasks. The role is expected to deputise for the Head of Viral Vector and take on short and long term delegations in team management capacity.

• Performing experimental planning, delegation of team actions, management of timelines, ensuring successful outcome;
• Design detailed project proposals based on client or internal specifications, prepare project costing, planning, resource forecast, and consumable estimates;
• Initiation, writing and support of deviations, investigations, change controls, CAPA’s, risk assessments, SOPs, policies, batch records, protocols and reports and other manufacturing related documentation in alignment with applicable GxP guidelines;
• Hands-on work in the development laboratory and cleanroom environment to support process development and manufacturing of Viral Vector products;
• Data analysis and report preparation with critical evaluation of results, identifying weak spots and possible sources of error, undertake follow-up actions;
• Collaboration with Analytics/QC to support assay development and validation;
• Monitoring of competitive landscape, technological developments, and continual update of self and team to ensure awareness of current state of the art;
• Communication with clients and collaborators supporting the identification of customer needs and proposing appropriate solutions;
• Engagement of potential customers during appropriate course of business activities e.g., conference attendance.

We expect a minimum of 5-10 years of recent immersion in the biopharmaceutical landscape, including a proven track record of both process development and GMP manufacturing operations or alternatively tech transfers between development and GMP. The role requires understanding of the science and practise of both USP and DSP operations with expert-level experience on either one. 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 executing Viral Vector development projects or manufacturing operations
• 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 or analysis.
• 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.