Technology Development and Integration Associate (TD&I Associate)

- (full-time) -

The position:

For the furthermore expanding of our Technology Development (TD) department we have an open position for a TD&I Associate. In this position you are responsible assisting the TD&I Expert during technology transfer and implementation of new assays in our facilities. In this position you are also responsible for ensuring the execution of assay, process and validation development activities.

Tasks and responsibilities:

  • Assist in the non-compendial assays transfer during technology transfer.
  • Gain understanding of new assays in details and transfer this knowledge to our facility.
  • Drafting and revising assay related documents as part of the method transfer and validation.
  • Execute experimental campaigns (cell culture and assays) for the assigned projects, ensuring that activities are performed according to applicable protocols and safety standards.
  • Support investigating equipment, material and procedure equivalency during TT
  • Generate and process experimental data, and report all laboratory activities in relevant lab books and log books.
  • Generate laboratory, technical, and quality documentation relevant to or resulting from transfer or development activities
  • Carrying out laboratory associated duties e.g. orders (internal and external), and logistic activities.

Qualifications and skills:

  • BSc, or MSc in biology, biotechnology, medical-technology or pharmaceutical sciences with preferably working experience in a QC environment.
  • Hands on experience with cell characterization techniques (e.g. FACS, qPCR, ELISA) and cell or tissue culture techniques (traditional and preferably automated platforms) is required.
  • Accuracy, well organized, problem solving, result driven, attention to detail, desire to work in a high paced environment, flexible, team player
  • Awareness of GMP, Quality regulations, documentation experience is recommended.
  • Working experience in a GMP setting (e.g QC or IVD settings) is highly recommended
  • Strong communication skills in English.

GMP Certification CMF Geleen

The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).

Fact sheet

GMP Certification CMF Maastricht

Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter.

Fact sheet