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Technology Development and Integration Expert - Netherlands  

Company managed [?] Still accepting applications

Posted on : 12 July 2017

Project Description

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, bio-sciences, bio-engineering. 
  • 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)