The Job is located in the Technical Services Group Department-technology transfer products. This assignment needs a Project Manager to help transition old processes into new process, writing to FDA.
The Manager Works directly for a Group Leader and will manage the timeline, change control activities in support of a new processing area at a manufacturing site. Provides oversight, counsel and advice to Group Leader and leadership on project activities and deliverables. Interacts with manufacturing site personnel and with cross functional teams from manufacturing, technical services, engineering, validation. Other responsibilities include authoring of regulatory submission documents in support of new processing area. Years of Experience 7-10 preferably in pharmaceutical aseptic manufacturing.