Summary: Supports the 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:
• 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.
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
For a confidential discussion and more information on the role/company please email your CV to: firstname.lastname@example.org