MSAT Upsteam Processing Expert (6079)

MSAT – Upstream Process Expert – 6079 URA

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a MSAT – Upsteam Process Expert  based in Visp, Switzerland for a 12-month contract with  great chances of extension.

As a member of the MSAT (Manufacturing Science & Technology) Team you will be responsible for the successful transfer, scale up, supervision and optimization of biopharma processes. As a very experienced professional, you are regarded as a senior expert in process science and manufacturing aspects. In this role, you significantly contribute to the development of the MSAT toolbox and share the manufacturing responsibility as a long-term process owner.

Main 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

 Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• PhD (preferred), 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