Investigator, MS&T
2 months ago
Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. The MS&T Specialist works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Other responsibilities include participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The MS&T Specialist works to identify and drive continuous improvements to the manufacturing process.
• Functions as a technology and process subject matter expert.
• Provides on-the-floor and on-site technical support to manufacturing when necessary.
• Author, review and approve, as needed, various documents (eg. Batch records, SOPs).
• Author and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer).
• Analyze and summarize manufacturing data to support impact assessments and investigations.
• Owner of change controls for process and procedure changes.
• Lead and executes CAPA system investigations.
• Leads technology transfer efforts for new processes and product implementation.
• Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
• Ability to perform gowning activities and enter the manufacturing plant.
• Some travel will be required.
Education or Equivalent Requirements:
• BSc and/or Advanced degree in Science or Chem/Bio Engineering
• Minimum 5 years of industry experience.
• Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
• Advanced degree(s) preferred
Knowledge/Skills Requirements:
• Scientific understanding in bioprocessing principles. Familiarity with cell therapy processes and cGMP is strongly preferred.
• Experience in Process qualification, validation
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus
• Experience with program management software and tools are a plus
• Experience working with external parties and/or cross-functional teams
• Experience interfacing with clients
• Possess strong verbal/written communication skills and ability to influence at all levels
• Ability to think strategically and to translate strategy into actions
• Ability to prioritize tasks in a highly dynamic environment
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