Added
1 day ago
Type
Full time
Salary
Salary not provided

Related skills

validation gmp cgmp fermentation bioprocess

๐Ÿ“‹ 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.

๐ŸŽฏ 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.

๐ŸŽ 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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