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.
Purpose: Reporting through the site manufacturing and technology head. Responsibilities: •Supporting and executing experimental design, data analysis and interpretation to...
Apply For This JobPurpose: Lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible to support the Process...
Apply For This JobPurpose: The role of New Product Introduction (NPI) Manager is responsible for the program management of overall scope, budget, schedule...
Apply For This JobPurpose: Reporting to the Utilities Lead, the purpose of this role is to be a Process Engineer supporting the WWTP....
Apply For This JobPurpose: Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs...
Apply For This JobPurpose: Reporting to the Suite Team Lead, as part of a multi-discipline team, specifically responsible for assisting the lead in...
Apply For This JobTo apply for this job email your details to niamh.wardrop@theaphexgroup.com.
To apply for this job email your details to niamh.wardrop@theaphexgroup.com.