Director, Sterile Engineering - Upper Gwynedd Township
6 days ago
Job summary
The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline.The FLEx Sterile Engineering Lead will steer this facility within the FLEx network.
Closely collaborate with operations and support groups from research global engineering (GES) site support functions GWES in developing formulations supporting sterile products using talent capabilities facilities of FLEx Center.
Responsibilities
- Oversee facility start-up readiness for FLEx capital project daily operation of FLEx equipment engineering automation bio-sterile validation maintenance calibration safety compliance requirements support development GMP activities.
- Maintain compliant GMP-licensed manufacturing facility capability manufacture supplies early late phase clinical trials multi-shift operation
Job description
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