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Location MD, Frederick
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.
Additional Notes "* Projects influence to assure alignment of site business processes with partners within MedImmune.
* Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills.
* Contacts are frequent with individuals representing other departments, and/or representing outside organizations
* Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation"
"* Projects influence to assure alignment of site business processes with partners within MedImmune.
* Good organizational skills
* Situational Leadership
* Decision making skills"
Req ID 6940
Position Category Manufacturing and Production