Our client is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. They harnesse science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
To support the development of the company in Dutch Limburg, we are looking for a (m/f):
Technology Development Expert
You are responsible for ensuring scientific and technological consistency of technology improvement, implementation and integration projects according GLP/GMP requirements.
- Lead assay transfer during technology transfer.
- Guarantee process/assay consistency investigating equipment, material and procedure equivalency during technology transfer.
- Evaluate validation data packages and design validation studies for processes and assays according to GMP requirements.
- Generate and review laboratory, technical and quality documentation relevant to or resulting from TD activities and report or present it.
- Provide scientific and technical content in both gap analysis and risk assessments.
- Ensure adherence of project specific activities with planned timelines and targets.
- Represent TD&I department in internal and external project specifics meeting.
- Master degree or PhD in Biotechnology, Biosciences or Bioengineering.
- Relevant experience in cell and gene therapy field, ideally with both viral and non-viral vectors.
- Strong knowledge of cell characterization techniques (FACS, qPCR, ELISA).
- Experience with Technology Transfer in GMP environment, focus on non-compendial assays.
- Broad experience in QC assay validation within GMP environment, ideally in an international setting and good understanding of GMP and ATMP regulatory framework.
- Team player, good organization and planning skills, result oriented, flexible, able to manage multiple projects independently.
- Excellent communication in English, both verbal and written.
- A challenging position within a high-potential innovative biotech company.
- To work in a dynamic, respectful and professional environment.
- International exposure, with learning and development opportunities.
- An attractive compensation package in line with the position responsibilities and your experience.