- Supports all upstream activities including raw materials and the process from vial thaw through harvest operations.
- Performs complex scientific process investigations with relevant departments as required.
- Demonstrate Technical and Scientific expertise in cell culture operations for daily monitoring, troubleshooting and investigations
- Provide technical floor support and on-call support for Manufacturing operations
- Leads cell culture investigations for the MFG operations
- Leads troubleshooting activities associated with the manufacturing process
- Performs product impact assessments and investigations.
- Writes and Reviews and approves investigation reports
- Reviews and/or approves Manufacturing documentation associated with the transferred process.
- Develops and writes protocols for manufacturing support activities.
- Lead technology transfer activities as needed
- Lead process and quality risk assessments
- Coach junior process scientists and process sciences associates
- Supports MFG Support Downstream and Process Validation activities as required.
- Presents findings at group and interdepartmental meetings
- Communicate information on current process data which may impact process development and/or technology transfer
- Liaise and communicate with senior management and communicate cross-functional and cross-site
- Requires a minimum of a PhD in Biochemistry, Chemistry, Biology or related field with 5+ years’ experience; advanced scientific degree such as an MS with 9+ years of relevant experience or Bachelors’ degree with 10+ years of relevant experience
- cGMP experience is desirable.
- Demonstrated problem-solving ability, strong interpersonal, oral, and written communication skills are essential. Strong mammalian cell culture background.
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email email@example.com