Process Development Expert
1 week ago
Our ideal candidate will have a bachelor's degree in chemical or biochemical engineering and 2 years of experience in a GMP environment. Additionally, they should have 1+ years of process engineering experience, preferably related to scale-up principles and commercial cGMP manufacturing facilities.
The successful candidate will have a background in biologics tech transfer into commercial facilities and knowledge of cell culture and/or purification processes. They will also have experience working with cell culture bioreactors, monitoring at-scale bioreactor processes and equipment, and working in a GMP plant and quality systems.
Key Responsibilities
- Transfer cell culture and/or purification drug substance processes from the laboratory into the manufacturing facility.
- Perform process improvements and provide technical support for successful scale-up, transfer of process technology, clinical/commercial manufacturing operation.
- Offer process validation support for late-stage commercial processes and provide routine process monitoring and troubleshooting.
- Execute data trending and statistical process analysis.
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