Key Accountabilities
- Coordinate and ensure the preparation and maintenance of documentation (e.g., SOP/WI, protocols/reports) within your area of expertise.
- Support the scaling-up from 200L to 2000L of suitable purification processes for manufacturing operations (Pre-clinical and Clinical).
- Assist your manager in coordinating activities within your scope of responsibility.
- Produce large-scale NBEs for pre-clinical or clinical studies.
- Provide small-scale production and laboratory services.
- Maintain a close relationship with the local Engineering and Technology organization as needed.
- Support the implementation of roadmap strategies and/or global initiatives.
- Keep your training plan up-to-date.
- Act as a Subject Matter Expert during audits related to large-scale manufacturing and technology transfer activities.