MSAT Expert e/v/e/r/y/o/n/e
Core
Lead the transfer, optimization, and validation of sterile drug product (DP) manufacturing processes for injectable therapies.
Role type
Senior MSAT Expert (Sterile Manufacturing)
Builds
Sterile manufacturing processes and injectable drug products
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Sterile manufacturing process transfer, Process validation (GMP), Root cause analysis, Change control management, CAPA management, Scale-up engineering, Data analysis for process deviations
Preferred skills
German language proficiency, Innovation in process improvement
Technologies
GMP, MSAT procedures, Engineering tools for scale-up
Responsibilities
Implement and optimize sterile DP processes, Support product and process qualification, Develop standardized MSAT procedures, Investigate process deviations and root causes, Drive technology assessments and scale-up projects, Lead continuous improvement initiatives
