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Principal Scientist - Process Development, Upstream

Catalent · Madison, WI

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Role summary

Catalent seeks a Principal Scientist to lead mammalian cell culture upstream process development activities, including bioreactor operations, DoE-based optimization, and tech transfer to cGMP manufacturing. The role involves managing multiple complex projects and providing technical leadership across cross-functional teams.

What they're looking for

  • Ph.D. in Biotechnology or related field with 8–10 years laboratory experience, or MS with 12+ years, or BS with 15+ years
  • Demonstrated experience developing and implementing upstream process methodologies with mammalian cell culture and bioreactors
  • Hands-on process development, scale-up, and cGMP manufacturing transfer experience
  • Strong expertise in Design of Experiments, process optimization, and parameter definition
  • Working knowledge of cGMP environments and good documentation practices
  • Strong technical writing skills for SOPs, batch records, protocols, and technical reports
  • Ability to lead multiple complex projects and provide technical mentorship

What you'll be doing

  • Lead development and implementation of mammalian cell culture upstream processing methodologies for cGMP transfer
  • Design and execute process development experiments including seed train scale-up and bioreactor operations
  • Apply DoE for clone screening, process optimization, and parameter definition
  • Troubleshoot process issues, execute corrective actions, and monitor outcomes to ensure project success
  • Support tech transfer activities and collaborate with internal teams and external clients on project delivery

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