MSAT Process Engineer
Machine translation — original language: Dutch.Show original
Strengthen the Manufacturing Science, Analytical & Technology (MSAT) team as the scientific pivot between development and large-scale GMP production. You will actively contribute to technology transfer of new biological medicines, process optimization, and continuous monitoring of existing upstream cell culture processes at the Sanofi site in Geel.
Your responsibilities
- Facilitating technology transfer of new drug substance processes from development laboratories to large-scale GMP production facilities
- Monitoring documentation readiness: process fit-gap analyses, process control strategies, media batch sheets, and sampling plans for clinical batch production
- Supporting process performance qualification for successful implementation at production scale
- Leading process improvement initiatives aimed at higher yield or robustness, including the development of supporting data packages
- Data trending and monitoring of existing commercial production processes
- Drafting scientific and technical study protocols and reports to support significant process changes
- Contributing to investigations and impact assessments during significant production deviations
- Collaborating closely with the laboratory team on lab-scale activities
Your profile
- Master or PhD in Life Sciences with a minimum of 3 years (PhD) or 5 years (Master) of relevant experience in process development or an MSAT-related role
- Hands-on experience with mammalian cell culture at lab and/or production scale; knowledge of purification processes is a plus
- Solid knowledge of cGMP; previous GMP experience is an asset
- Analytically strong, accurate, and detail-oriented
- Fluent in English (oral and written); international working environment
- Familiar with statistical techniques and data trending; experience with JMP, Statistica, Matlab, or Simca is a plus
- Flexible: willing to work occasional evening or weekend shifts and switch between lab and production scale
- Strong interpersonal skills and a team player in multidisciplinary environments
Contact person
Listed by the employer in the job posting — for questions and your application.
- Anais Malikian