Principal Process Scientist:
This position will support the upstream manufacturing team and troubleshoot manufacturing processes.
• Supports all upstream activities including raw materials and the process from vial thaw through harvest operations.
• Performs complex scientific process investigations with relevant departments as required.
• Demonstrate Technical and Scientific expertise in cell culture operations for daily monitoring, troubleshooting and investigations
• Provide technical floor support and on-call support for Manufacturing operations
• Leads cell culture investigations
• Leads troubleshooting activities associated with the manufacturing process
• Performs product impact assessments and investigations.
• Writes and Reviews and approves investigation reports
• Reviews and approve Manufacturing documentation associated with the transferred process.
• Develops and writes protocols for manufacturing support activities.
• Lead technology transfer activities as needed
• Lead process and quality risk assessments
• Coach junior process scientists and process sciences associates
• Supports Downstream and Process Validation activities as required.
• Presents findings at group and interdepartmental meetings
• Communicate information on current process data which may impact process development and/or technology transfer
• Liaise and communicate with senior management and communicate cross-functional and cross-site
- PhD in Biochemistry, Chemistry, Biology or related field with 5+ yrs experience.
- Advanced scientific degree such as an MS with 9+ years of relevant experience or
- Bachelor’s degree with 10+ years of relevant experience cGMP experience is desirable.
- Demonstrated problem-solving ability, strong interpersonal, oral, and written communication skills are essential. Strong mammalian cell culture background.
For more information or a confidential discussion contact Deirdre Sheehan on 061 512270 firstname.lastname@example.org