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
- 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
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
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...