Scientist Role in Product Transfer and Validation
The company seeks a skilled MSAT Scientist to support product transfers and related activities, such as process and cleaning validation.
This role involves ongoing monitoring and support of manufacturing processes, including leading process optimisation and investigating root causes when issues arise.
Responsibilities:
* Lead and coordinate Tech Transfer (TT) activities for new products and processes
* Create production instructions and required protocols
* Review data, schedule activities, and support manufacturing teams
* Apply risk-based approach to planning and execution
* Collaborate cross-functionally to resolve TT issues
* Provide on-floor support and implement data-driven performance metrics
Requirements:
* Master's in a technical field; PhD a plus
* 5+ years in biotech/pharma with NPI and product support experience
* Strong understanding of manufacturing for oral solids, injectables, or biologics
* Skilled in process validation documentation and execution
* Vaccine and cleaning validation experience a bonus