Summary: Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The group is made of six main functional teams namely:
- Upstream Sciences
- Downstream Sciences
- Analytical Technologies Team
- Data Analytics and Modelling
- Manufacturing Support & Process Validation
- Project Management and Operations
This position is a leadership role within the Process Validation team.
Essential Duties and Responsibilities may include, but are not limited to, the following:
- Draft process validation protocols for both process performance qualification and associated studies.
- Defines Process Validation Strategies
- Author, review and approve protocols and reports associated with process validation programs (e.g. process verification/process performance qualification, media/feed/buffer preparation and storage, process intermediate extended hold, chromatography column/filter sanitization and storage, and LIVCA).
- Develops and writes protocols for production support activities.
- Provides technical expertise (and may facilitate) process risk assessments (e.g. FMEAs). Work collaboratively within multi-functional teams to help ensure that process risks are identified, reviewed and appropriately controlled.
- Presents validation data to FDA and other regulatory agencies.
- Champion in cell culture and downstream operations for daily monitoring, troubleshooting and investigations
- Performs scientific process investigations with relevant departments as required.
- Provide on the floor support to Manufacturing (Cell culture and Purification)
- Performs product and process impact assessments.
- Participates in or Lead process and quality risk assessments.
- Presents findings at group and at interdepartmental meetings.
- Communicates information on current process data which may impact Process Validation.
Knowledge and Skills:
- Experience in process validation within the biotech industry with knowledge of manufacturing processes and biological products preferred.
- The ability to work optimally in a fast-paced environment with changing priorities and a high level of urgency.
- Good verbal and written communication skills; ability to converse about technical concepts to internal management.
Education and Experience:
- Bachelor, Master, or Doctorate degree in Life Sciences, Biological/Chemical Sciences, or Process/Chemical Engineering.
- A minimum of a BA/BS and a with 5 years relevant experience, MS with 4 years, or PhD with 0-2 years.
- cGMP experience is desirable.
