Lead Assay / Analytical Development for Viral Vector

  • Location:
    Leiden, NL
  • Education:
    Academic

Leiden, NL – Bio Science Park

The Position

Are you a specialist in analytics for gene therapy research and production processes? This is your chance to be at the forefront of establishing a state-of-the-art development and production facility for 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 Lead of Assay/Analytical Development 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 varied and novel development projects.

Your responsibilities furthermore include:

  • Development and implementation of the appropriate assays for gene therapies both in-process control and product release;
  • To undertake novel assay 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).

About NECSTGEN

At NECSTGEN we challenge today’s possibilities to get more cell and gene therapies into the clinic and to the patient. NECSTGEN spun out of the Leiden University Medical Center (LUMC) by recognizing the needs of specifically early-stage research organizations and start-ups to efficiently develop cell and gene therapies.

NECSTGEN is not a regular CDMO but a centre of expertise with a unique position enabling us to solely dedicate our resources to delivering high quality services, accessible for early stage research organizations.

NECSTGEN supports the translation of novel therapies and technologies to GMP operations and clinical trials. 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 non-profit 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.

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.

What we ask

We are looking for a specialist in assay development with extensive experience with gene therapy production processes (using Lentiviral, Adenoviral or AAV).

Furthermore, you bring:

  • Educational background in Biology, Biotechnology, Biochemical Engineering or related (MSc or PhD);
  • Experience in flow cytometry, ELISA and PCR-based techniques;
  • A minimum of 5 years of experience in GMP or tech transfer from R&D to GMP.

Offer

As Lead Assay Development you will enjoy the best of both worlds; the culture, dynamics and excitement of a start-up and the benefits of an established institute. In addition to your salary you will receive 8% holiday allowance and a 13th-month payment.

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.

Application closes November 20 or earlier in case of a suitable candidate. First option for interviews is scheduled for November 4.

 


Head of Production

Netherlands Center for the Clinical Advancement of Stem Cell & Gene Therapies

NECSTGEN LOGO

Netherlands Center for the
Clinical Advancement of
Stem Cell & Gene Therapies

NECSTGEN

Visiting adress
Sylviusweg 62
2333 BE Leiden
Leiden Bio Science Park
The Netherlands

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