MSAT USP Expert

MSAT USP Expert

Location : Valais

Duration : 02 / 09 / 2024 to 31 / 08 / 2025

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), 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

If this role is of interest to you, or anyone from your network, feel free to send me your CV and expected hourly rate for immediate consideration.

I am specialised recruiter taking care of various projects within the Life Sciences Industry.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.