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 provides 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 next steps during setup of our facility. You will be involved in recruiting and training future team members and work on development projects.

Your responsibilities also include:

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

Job requirements


What we ask


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

Furthermore, you bring:

  • An 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 and enable the unthinkable. We truly make a difference in people’s lives by offering more cell and gene therapies to the patient. The Netherlands Center for the Clinical advancement of Stem Cell and Gene Therapies (NecstGeN ) primarily enables early-stage research organizations and start-ups with efficiently developing their novel cell and gene therapies. Ultimately we expect that NecstGeN will engage with organizations of all scales worldwide.


NecstGeN is a spin-out of the Leiden University Medical Center (LUMC), which is our only shareholder. This enables us to not just be a CDMO but a center of expertise in a unique position. We recently signed a 15-year rental agreement to realize a 4,000 m2 facility which includes13 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 services, including fill and finish. We 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. Visit our LinkedIn company page to learn more about our team and the latest developments.



Offer


As USP Lead for Viral Vector you will be able to enjoy the culture, opportunities, and excitement of a new organization, PLUS all the benefits and security of an established institute. At NecstGeN you will be challenged to leverage your skills and expertise and make an impact on people’s lives. At NecstGeN we believe that people are the foundation of our success. That’s why 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.

Do you recognize yourself in this application? Please get in contact with us! Don’t hesitate to contact Evelien Luijt (Interim Recruiter) at e.l.luijt@lumc.nl for more information.