04 Apr Validation process Leader Consultant – BELGIUM
- Executes validation studies at the bench and in a manufacturing setting.
- Facilitate multiple aspects of process qualification strategy through designing/ authoring/executing/reporting/ investigation of process qualification studies.
- Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.
- Responsible to initiate and execute Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations.
- Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices.
- Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing
- Supports process validation as a team leader for overall project scope.
- Bachelor’s degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field; minimum of 5 years relevant experience and/or training; or equivalent combination of education and experience.
- Knowledge and several years’ experience (>5) in facilitating multiple aspects of a process validation strategy through designing/authoring/executing/reporting/investigating process validation studies.
- Knowledge and experience to lead process validation studies at the bench and in a plant setting.
- Knowledge and experience in the development of manufacturing control strategies, methods and techniques in filtration, purifying, identification and control of impurities.
- Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE).
- An attractive and competitive salary with fringe benefits
- A challenging & innovative environment with space for individual initiative & personal growth
- Training opportunities if needed