Technology Development and Integration Expert for project - Netherlands
- As part of our participation in the EU funded project , we have one open position for a TD&I Expert within our Technology Development (TD) department. In this position you are responsible for ensuring successful achievement of Netherlands Deliverable within the EU project.
- This opening would be ideal for profile with relevant experience in a research setting aiming at transitioning toward an industrial career.
- More junior profile might be considered as TD&I Associate for this position.
Tasks and responsibilities:
- Investigate process and assays feasibility and provide scientific and technical content in both gap analysis and risk assessments.
- Develop and provide implementation and scale up recommendations for both assays and processes focusing on translation of product from preclinical into clinical stage (under GMP).
- Ensure adherence of project specific activities with planned timelines and targets.
- Generate and review project related documentation and reports relevant to or resulting from TD activities
Qualifications and skills:
- MSc or PhD in biotechnology, biosciences, bioengineering or regenerative medicine.
- Strong knowledge of cell characterization techniques (e.g. FACS, qPCR, ELISA) and bioprocess development/implementation approaches (traditional and automated platforms).
- Strong Understanding of GMP and ATMP regulatory framework, and product development throughout clinical stages (from preclinical to commercial).
- Relevant experience in the field of cell and gene therapy including in assay and process development within GMP environment in an international setting
- Relevant experience in diabetes and therapeutic approaches based on ATMP will be a plus
- Relevant experience with European funded research projects will be a plus
- 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)