Technology Development and Integration Expert - Netherlands
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- 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)