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, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
My company shares my passion for helping to improve human health around the world.
This is My MedImmune
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
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