Job - Skilled - Recruitment Solutions GmbH
Aufgaben
- Lead cross-functional teams as a process expert, overseeing technology transfers (process design and scaling up) and timely implementation of processes at the production scale. This includes managing the entire project lifecycle from planning and coordination to implementation, control, and project completion, in alignment with project management goals.
- Act as the liaison between the process provider (customer, process development) and operations, ensuring process scalability and manufacturability.
- Ensure successful technology transfer by applying formal processes and tools to manage information exchange, process-related risks, and change control.
- Resolve process issues that may arise during production, considering all regulatory requirements.
- Conduct GMP risk analyses for manufacturing processes.
- Serve as an MSAT process expert in capital investment projects for the construction and commissioning of production units, responsible for delivering all necessary inputs for specific processes (block flow diagrams, media and buffer lists, critical parameter lists).
- Implement the manufacturing process in the facility.
- Interact directly with customers during technology transfer, campaign preparation, execution, and closure, including daily reporting on batch status and performance.
- Ensure timely compilation of process deviations, change requests, and campaign reports.
- Prepare CMC sections for submission documents and technical content of validation reports.
- Contribute to the development and implementation of standardized MSAT procedures and processes.
- Drive continuous improvement in process performance.
- Supervise tasks related to local and global MSAT initiatives or lead major task forces and troubleshooting teams.
- Evaluate and advance innovative trends within the respective field of expertise.
- Provide mentorship to scientific and production staff across various disciplines.
- Conduct process-specific training for production personnel.
Qualifikationen
- PhD preferred, or a Master’s degree in Biotechnology, Chemical Engineering, or related disciplines.
- Professional experience in biopharmaceutical production and/or process development, preferably in mammalian cell culture.
- Deep understanding of GMP and bioprocess technology.
- Excellent communication skills with the ability to interact effectively with various stakeholders within customer and project organizations.
- Fluent in English required; proficiency in German is a plus.
Über die Firma