Principal Scientist - Process Development, Upstream

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.

Responsibilities

• 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

Requirements

• 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