Summary:Supports the Upstream Manufacturing Support Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Supports all upstream activities including raw materials and the process from vial thaw through harvest operations.
• Performs scientific process investigations with relevant departments as required.
• Technical and Scientific expertise in cell culture operations for daily monitoring, troubleshooting and investigations
• Provide technical floor support for Manufacturing operations
• Leads cell culture investigations for the MFG operations
• Leads troubleshooting activities associated with the manufacturing process
• Performs product impact assessments.
• Applies statistical process control tools in monitoring the manufacturing process.
• Reviews and/or approves Manufacturing documentation associated with the transferred process.
• Develops and writes protocols for manufacturing support activities.
• Supports technology transfer activities as needed
• Authors Process Validation protocols and report activities.
• Participates in process and quality risk assessments
• Supports MFG Support Downstream and Process Validation activities as required.
• Presents findings at group and possibly at interdepartmental meetings
• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer
Education and Experience:
• PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. cGMP experience is desirable.
• Candidates with an MSc in Biotechnology or a related field with 3+ year’s relevant experience will also be considered.
If you would like further Information you can contact the recruiter directly:
Libby Ryan | Tel: +353 (0) 1 507 9254