For the furthermore expanding of our Technology Development (TD) department we have an open position for a TD&I Manager for our sites in Maastricht and Geleen. 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:
- Investigate project/process/assay feasibility and provide implementation recommendations during commercial proposal generation for new clients.
- Guarantee process/assay consistency investigating equipment, material and procedure equivalency during technology transfer or other activities.
- 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.
- Provide scientific and technical content in both gap analysis and risk assessments.
- Develop and implement assays, procedures and production processes and related equipment to keep the company at the forefront of the state-of the art cell and gene therapy industry.
- 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 including ideally in assay and process validation within GMP environment in an international setting.
- Strong knowledge of cell characterization techniques (e.g. FACS, qPCR, ELISA) and bioprocess development/implementation approaches (traditional and automated platforms).
- Broad experience in the field of ex vivo gene therapy with both viral and non-viral vectors.
- Good understanding of GMP and ATMP regulatory framework, and Technology Transfer.
- Planning and organizing skills, result driven, flexible, ability to manage independently multiple projects, team player.
- Good communication skills in English (verbally and written)