The candidate will also be responsible for manufacturing technology transfer activities, including but not limited to sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as at-scale/full scale process development studies, protocols, and reports. Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, JMP, Visio, and Adobe Pro, would be an advantage.