Upstream Process (USP) Lead for Viral Vector

Job description

Are you a specialist in optimizing upstream processes of viral vector production? This is your chance to be at the forefront of establishing a state-of-the-art development and production facility for the development and production of cell and gene therapies. Contact us today because we need you to make NECSTGEN happen!



What you will do 


NECSTGEN will provide expert knowledge for the development, production and commercialization of cell and gene therapies to a variety of collaborators and customers at various stages of the therapy life cycle.

While working towards GMP certification in early 2022 you as USP Lead Viral Vector Production will play a key role in the further setup of the facility while we work towards the first GMP run. You will be involved in recruiting and training future team members and work on development projects.

Your responsibilities furthermore include:


  • Development and implementation of appropriate upstream processes for gene therapies.
  • To undertake novel development projects to provide solutions for a variety of gene therapies;
  • Technology transfer from R&D to GMP environment;
  • Selection and evaluation of technologies and equipment, managing implementation activities such as IQ/OQ/PQ;
  • Writing and reviewing of GMP documentation, including batch records and equipment SOPs (coordination of and hands-on);
  • Training and recruitment of future viral vector team members;
  • Support of activities like aseptic process validation (APV).

Job requirements


What we ask

We are looking for a specialist in USP with extensive experience with viral vector production processes using lentivirus or adeno associated virus.

Furthermore, you bring:

  • Educational background in Biology, Biotechnology, Biochemical Engineering or related (MSc or PhD);
  • A minimum of 5 years of experience in GMP or tech transfer from R&D to GMP.


About NECSTGEN

Together with our clients and partners we challenge today’s possibilities to enable the unthinkable and make a difference in people’s lives by getting more cell and gene therapies to the patient.

The Netherlands Center for the Clinical advancement of Stem Cell and Gene Therapies (NECSTGEN) will primarily enable early-stage research organizations and start-ups to efficiently develop novel cell and gene therapies. Ultimately it is expected that NECSTGEN will engage with organisations of all scales worldwide.


NESCTGEN is a spin out of the Leiden University Medical Center (LUMC) which is our only shareholder. This enables us to be not just a CDMO but a centre of expertise with a unique position. Our aim is to dedicate our resources to deliver high quality services, accessible to early stage research organizations and start-ups to develop novel cell and gene therapies. We recently signed a 15-year rental agreement to realize a facility of close to 4,000 m2 space including 13 cleanrooms for novel cell and gene therapy production.

NECSTGEN supports the translation of novel therapies and technologies to GMP production. We offer development and GMP manufacturing services, including fill and finish and bring together expertise from R&D, process development including analytical, Quality Assurance, Quality Control, Regulatory Affairs, Business Development and Manufacturing in a purpose-built GMP production facility.

Our current team consists of professionals from industry and academia with an entrepreneurial mind-set and a drive to make a difference. We are a flat organization with a participative management style.


Offer

As USP Lead for Viral Vector you will enjoy the best of both worlds; the culture, opportunities and excitement of a new organistion with all the benefits and security of an established institute. At NECSTGEN you will be challenged and supported to leverage your skills and expertise to make an impact on people’s lives and the opportunity to grow with the company.

At NECSTGEN we believe that people are the foundation of our successes and hence we invest in excellent benefits, a healthy supportive working environment, flexible hours, and training & development. A fulltime position at NECSTGEN consists of a 36-hours workweek. In addition to a competitive salary you will receive:


  • 8% holiday allowance;
  • A 13th-month payment;
  • An excellent pension and insurance plan.


If this position sparks your enthusiasm, we would love to hear from you! Don’t hesitate to contact Geertje Janssen at g.janssen@necstgen.com or +31(0) 6 15 93 34 54 for more information.