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.