Job Summary
We are seeking a highly skilled Process Expert to lead cross-functional teams in technology transfers and process implementation at manufacturing scale. This role involves managing projects from planning to completion, ensuring scalability and manufacturability of processes, and resolving issues that may arise during manufacturing.
Key Responsibilities
* Lead cross-functional teams as a process expert in technology transfers, process design, and up-scaling for timely process implementation at manufacturing scale.
* Serve as the interface between the process donor and operations, ensuring process scalability and manufacturability.
* Secure success during technology transfer by applying formal processes and tools to manage information transfer, process-related risks, and change control.
* Resolve process issues that may arise during manufacturing, considering all regulatory requirements.
* Execute GMP risk analysis for manufacturing processes.
* Work as an MSAT process expert in Capital investment projects for building and commissioning of manufacturing units.
* Implement manufacturing processes in the plant.
* Interact directly with customers during tech transfer, campaign preparation, execution, and closure.
* Compile process-related deviations, change requests, and campaign reports in a timely manner.
* Contribute to the development and implementation of standardized MSAT procedures and processes.
* Ensure continuous improvement of process performance.
* Supervise tasks related to local and global MSAT initiatives or lead major task forces or troubleshooting teams.
* Evaluate and drive innovative trends within the respective area of expertise.
* Act as a mentor for scientific and production staff in different fields of expertise.
* Perform 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, preferably in mammalian manufacturing.
* Deep understanding of GMP and bioprocess technology.
* Excellent communication skills and interaction with various interfaces within customers and project organizations.
* Fluency in English required; German is a plus.