Purpose:

Supports the Process Sciences Department with analysis, troubleshooting, and process validation of manufacturing bioprocesses.

Responsibilities:

• 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.

Minimum Qualifications and Experience:

• 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.