Unlock the Secrets of Biopharma Manufacturing
In this challenging role, you will take ownership of process science and manufacturing aspects. You will significantly contribute to the development of our MSAT toolbox and share the manufacturing responsibility as a long-term process owner.
Your Key Responsibilities:
* Secure successful technology transfer by applying formal processes and tools to manage information, process-related risks, and change control.
* Manage technical risks associated with process transfer, identify new raw materials, and project completion aligned with project management goals.
* Ensure communication of critical process and technical information to meet deadlines and customer outcomes.
* Act as an interface between process donors and operations, ensuring process scalability and manufacturability.
* Resolve process issues during manufacturing, considering regulatory requirements.
* Execute GMP risk analysis for manufacturing processes.
* Implement manufacturing processes in the plant.
* Provide 24/7 on-plant technical support, process monitoring, and complex data analysis.
* Interact directly with customers during tech transfer, campaign preparation, execution, and closure.
* Compile process-related deviations, change requests, and campaign reports.
* Contribute to standardized MSAT procedures and processes.
* Lead technical investigations to ensure continuous improvements.
Your Requirements:
* Bachelor's or Master's degree in biotechnology, chemical engineering, or related disciplines.
* Working experience in biopharma manufacturing and/or process development, preferably in mammalian manufacturing.
* Understanding of GMP and bioprocess technology.
* Excellent communication skills and interaction with various interfaces within customers and project organizations.
* Fluency in English.