Technology Development and Integration Expert(TD&I Expert.)

- (full-time) -

The position:

For the furthermore expansion of our Technology Development (TD) department, we have one open position for a TD&I Expert. In this position you are responsible for ensuring scientific and technological consistency of technology improvement, implementation and integration projects according GLP/GMP requirements.

Tasks and responsibilities:

  • Guarantee process/assay consistency investigating equipment, material and procedure equivalency during technology transfer.
  • Lead non-GMP phase of non-compendial assay transfer during technology transfer.
  • Evaluate validation data packages and design validation studies for processes and assays according to GMP requirements.
  • Represent TD&I department in internal and external project specific meetings
  • Provide scientific and technical content in both gap analysis and risk assessments.
  • Ensure adherence of project specific activities with planned timelines and targets.
  • Generate and review laboratory, technical and quality documentation relevant to or resulting from TD activities and report or present it.

Qualifications and skills:

  • MSc or PhD in biotechnology, biosciences, bioengineering.
  • Relevant experience in the field of cell and gene therapy (ideally with both viral and non-viral vectors)
  • Strong knowledge of cell characterization techniques (e.g. FACS, qPCR, ELISA)
  • Broad experience in QC assay validation within GMP environment ideally in an international setting
  • Ideally significant experience with Technology Transfer in a GMP environment (Focus on non-compendial Assays).
  • Experience with bioprocess development (traditional and automated platforms) would be a plus.
  • Good understanding of GMP and ATMP regulatory framework
  • Planning and organizing skills, result driven, flexible, ability to manage independently multiple projects, team player.
  • Able to manage priorities, under stress and at short notice
  • Excellent communication skills in English.(verbally and written)

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