- Reference: GJ42932y
- Job Type: Permanent
- Location: Clare, Galway, Limerick
- Category: Science, Pharmaceutical & Food
Supports the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
• Leads scientific process investigations with relevant departments as required.
• Leads and authors Process Validation protocols and report activities.
• Performs product impact assessments.
• Develops and writes protocols for manufacturing support activities.
• Serves as a subject matter expert (SME) for data trending and manufacturing support activities
• 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
• Applies statistical process control tools in monitoring the manufacturing process.
• Investigates OOS and OOL IPCs
• Leads or Participates in process and quality risk assessments
• Presents process monitoring data to IOPS Management as necessary
• Assists in troubleshooting activities associated with the manufacturing process
• Supports technology transfer activities as needed
• Reviews and/or approves Manufacturing documentation associated with the transferred process.
Skills, Experience and Qualifications:
• PhD in Biotechnology, Biochemistry, Chemical Engineering or a related field with 3+ years experience; may consider another discipline with added relevant experience. cGMP experience is desirable.
• Candidates with an MSc Biotechnology or related field with 6+ years experience will also be considered. cGMP experience is desirable.