MSAT USP Expert LZAJP00004425
Key Responsibilities
- Leading cross-functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals
- Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability
- Securing success during technology transfer by applying formal processes and tools to manage the transfer of information, process related risks and change control
- Responsible for the resolution of process issues that may arise during manufacturing, considering all regulatory requirements
- Responsible for execution of GMP risk analysis for the manufacturing processes
- Working as MSAT process expert in Capital investment projects for building and commissioning of the manufacturing units. Main responsible for delivering all input required for the specific processes (block-flow diagrams, media and buffer lists, critical parameter lists)
- Responsible for implementing the manufacturing process in the plant
- Interacting directly with customers during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance
- Ensuring timely compilation of process related deviations, change requests and campaign reports
- Compiling CMC sections in filing documents and technical content of validation reports
- Contributing to the development and implementation of standardized MSAT procedures and processes
- Responsible for continuous improvement of process performance
- Supervising tasks in the area of local and global MSAT initiatives or leading major task forces or troubleshooting teams
- Evaluating and driving innovative trends within the respective area of expertise
- Acting as a mentor for scientific and production staff in different fields of expertise
- Performing process specific trainings for production staff
Key Requirements
- • PhD (preferred) or Master’s degree in biotechnology, chemical engineering or related disciplines
- Working experience in biopharma manufacturing and / or process development preferable in of Mammalian Manufacturing
- Deep understanding of GMP and bioprocess technology
- Very good communication skills and interaction with all kinds of interfaces within customers and the project organization
- Fluency in English required, German a plus
À propos de l'entreprise
