MSAT Process Expert Mammalian Upstream Large-Scale (m/f/d)

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.

Bachelor / Master's degree, PhD preferred

Preferred area of study:  Biotechnology, chemical engineering or related disciplines

More than 5 years of experience in the area of biopharma manufacturing and / or process development preferable in the area of Mammalian Manufacturing

GMP and deep understanding of bioprocess technology

Fluency in English. German is a plus.

Strong leadership skills

Very good communication skills and interaction with all kinds of interfaces within customers and the project organisation

Strong team orientation

Structured, focused and well-organized working attitude

Open-minded for new ideas and suggestions

Agile, highly motivated and dynamic drive

Solution-oriented