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Senior Scientist - Downstream Process Development, mRNA

Catalent · Madison, WI

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Role summary

Catalent Pharma Solutions seeks a Senior Scientist to lead downstream process development for mRNA therapeutics and vaccines. The role encompasses process design, optimization, analytical support, and technology transfer across clinical and commercial programs in Madison, Wisconsin on a full-time, on-site basis.

What they're looking for

  • Bachelor's in STEM with 8-15 years experience, or Master's with 5-10 years, or Doctorate with 2-4 years
  • Hands-on expertise in mRNA in vitro transcription, purification, and analytical characterization
  • Process-scale chromatography and filtration experience in industrial settings
  • Knowledge of cGMP environments, good documentation practices, and aseptic techniques
  • Experience with process scale-up, technology transfer, and viral clearance validation
  • Ability to write SOPs, batch records, and process development reports
  • Experience mentoring junior staff on laboratory procedures and scientific projects

What you'll be doing

  • Design and optimize in vitro transcription reactions, enzymatic processing, and purification workflows
  • Develop scale-down models and execute design-of-experiments studies for process characterization
  • Define control strategies for mRNA drug substance including critical process and quality parameters
  • Collaborate with analytical teams on method development, validation, and suitability assessments
  • Support technology transfer activities to GMP manufacturing sites for mRNA and protein programs

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