MSAT Process Expert
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Job Description:
We are seeking a highly skilled MSAT Process Expert to lead technology transfers and implement manufacturing processes from design to full-scale production. This key role serves as a link between development and operations, interacting directly with customers, preparing regulatory documentation, and driving continuous improvement.
Key Responsibilities:
* Secure successful technology transfer by applying formal processes and tools to manage the transfer of information, process-related risks, and change control.
* Manage technical risks associated with process transfer, identify new raw materials, and ensure project completion aligned with project management goals.
* Ensure communication of critical process and technical information to meet required deadlines and customer outcomes.
* Act as an interface between the process donor and operations, ensuring process scalability and manufacturability.
* Resolve process issues that may arise during manufacturing, considering all 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.
Key Requirements:
* PhD or equivalent experience (preferred), Master's degree or equivalent experience in biotechnology, chemical engineering, or related fields.
* Working experience in biopharma manufacturing and/or process development, preferably in Mammalian Manufacturing.
* Experience in technology transfer for Mammalian Manufacturing (preferred).
* Understanding of GMP and bioprocess technology.
* Excellent communication skills and interaction with various interfaces within customers and the project organization.
* Proficiency in English.
Becoming Part of Our Team:
You will be part of a global leader in life sciences operating across five continents. We work in science, driven by talented people working together, devising ideas that help businesses improve lives. In exchange, we let our people own their careers, allowing them to genuinely make a meaningful difference.