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validation gmp cgmp fermentation bioprocess๐ Description
- Support GMP DS manufacturing operations through process development.
- Improve equipment, enable technology transfer, and data analysis.
- Provide engineering oversight across cross-functional teams.
- Represent DS in equipment validation, regulatory submissions, and inspections.
- Provide training, troubleshooting, process trending, and hands-on cGMP production.
๐ฏ Requirements
- Bachelor's degree in biological sciences, chemical engineering, or related discipline.
- 5 years of pharma/biotech manufacturing experience.
- Advanced experience in a cGMP environment.
- Intermediate experience with fermenters (100 L+), UF/DF, and chromatography.
- Experience with regulatory submissions and GMP docs.
- Experience with JMP, SAS, or R software.
๐ Benefits
- Competitive compensation with annual bonus.
- Generous PTO, holidays, and parental leave.
- Healthcare, HSA and 401k matching; life and disability insurance.
- Pet insurance; wellness discounts.
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