Associate Process Scientist (Manufacturing Support)
Regeneron
Limerick, Ireland
Within the role you will support the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
As a Associate Process Scientist, a typical day might include, but is not limited to, the following:
- Provides on the floor MFG support;
- Coordinates samples from MFG for lab analysis;
- Coordinates and manages MFG Support trackers;
- Attends routine MFG and deviation meetings;
- Authors Process Validation protocols and report;
- Performs product impact assessments;
- Investigates OOS and OOL IPCs;
- Data mining and retrieval for colleagues for quality investigations;
- Serves as liaison between Rensselaer and Raheen for Change Notification;
- Develops and writes protocols for manufacturing support activities;
- Presents findings at group and possibly at interdepartmental meetings;
- Communicates information on current process data which may impact process development and/or technology transfer;
- Participates in process and quality risk assessments;
- Presents process monitoring data to IOPS Management as necessary;
- Assists in troubleshooting activities associated with the manufacturing process;
- Supports technology transfer activities as needed;
- Reviews Manufacturing documentation associated with the transferred process.
To be considered for this opportunity you should have a BS/BA in Life sciences/Engineering or related field. May consider another degree discipline with relevant experience; cGMP experience is desirable.
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