This position is a leadership role within the Process Validation team for a Process Validation Scientist.
• 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.
• 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.
• 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.
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