Job Description
- Manufacturing process trending, participating in process validation activities, providing technical support, drafting technical justifications and process understanding by process mapping
- Additional activities include the design, execution, and interpretation of experiments to perform process characterization, evaluate novel technologies, identify process improvements, drafting risk assessments and providing technical expertise to support regulatory submissions
- A basic understanding of cell culture or fermentation biology, process scale-up and statistical methods is essential.
- Hands-on experience working in the lab, aseptic technique, cell culture and bioreactor operations, to support the routine responsibilities with solid scientific data is also desirable.
- The position necessitates extensive interaction with manufacturing, quality, purification process development as well as CMC/Regulatory Affairs groups
Requirements:
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