Supports the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.
• Performs scientific process investigations with relevant departments as required.
• Authors Process Validation protocols and report activities.
• Performs product impact assessments.
• Develops and writes protocols for 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.
• 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.
• PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience.
• MSc in Biotechnology, Biochemistry or a related field with 3+ years’ experience.
• May consider another discipline with added relevant experience.
• cGMP experience is desirable.
Purpose: The Cell Culture Specialist Technical Services has primary responsibility for providing scientific & technical support of (cell culture-derived) drug...Apply For This Job
Purpose: A vacancy exists within the Site Projects Group for a Mechanical Project Engineer supporting site Capital & Expense projects....Apply For This Job
Purpose: Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs...Apply For This Job
Purpose: Supports the Process Sciences Department through process monitoring and statistics. To establish, organise and maintain effective statistics and data...Apply For This Job
Purpose: Supports the Process Sciences Department through small scale laboratory experiments, as well as analysis, troubleshooting, and validation of manufacturing...Apply For This Job