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.
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