Manufacturing Specialist
MedImmune - Frederick, MD

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The primary role of the Manufacturing Specialist is to support the operation and continuous improvement of the Manufacturing Department by executing the following:
  • Implementing continuous improvement initiatives/ projects to improve safety, quality, efficiency and/or regulatory compliance.
  • Coordinating and ensuring successful completion of tech transfer projects/ activities for the Manufacturing Department
  • Investigating, tracking and facilitating closure of higher level Manufacturing non-conformances
  • Authoring, executing and facilitating closure of VSCRs and CAPAs.
  • Leading the authoring and revision of batch records and SOPs
  • Anticipate potential issues and conflicts and present options for resolution to functional management in a clear and concise manner.
  • Build and maintain strong relationships with department leads and other stakeholders to ensure effective communication of production plans and issues.
  • Partner with line management in prioritizing projects and resources to meet business goals
  • Assist with technician training
  • Identify and implement programs and projects to ensure the smooth and continuous operation of manufacturing
~BSP

Position:
  • Knowledgeable of application and practices of current Good Manufacturing Practices (cGMP's), international regulatory requirements and guidelines (such as European directives, ICH guidelines and European and Japanese pharmacopeia requirements
  • Knowledgeable of late stage clinical and commercial manufacturing regulatory requirements and best practices
  • Sufficient understanding of biopharmaceutical process, systems and equipment to troubleshoot problems and provide solutions to management
  • Expert knowledge of electronic quality systems
  • Knowledgeable in current processes and equipment for biopharmaceutical manufacturing
  • Possesses strong verbal and written communication skills
  • Knowledgeable of troubleshooting/ root cause analysis tools
  • Working knowledge of Lean Manufacturing, Six Sigma or other continuous improvement tools preferred
Education:
B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study.
  • 5-7 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors. 3-5 years experience with Masters degree.

MedImmune - 23 months ago - save job
About this company
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MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...