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Manufacturing Innovation Specialist

MedImmune, LLC

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Location:
Frederick, MD
Posted Date:
7/28/2014
Position Type:
Job Code:
8133
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The primary role of the Manufacturing Technology Innovation Specialist is to identify, plan and implement innovative technological programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost effective manner. Major areas of responsibility include the following:
* Build and maintain strong relationships with key stakeholder such as product development groups as well as customer, corporate and site based science and technology groups to ensure the desired technology programs are planned and implemented to support Manufacturing Operations' needs.
* Primary Manufacturing Operations interface for New Product Introductions
* Coordinating and ensuring successful completion of tech transfer projects/ activities for the Manufacturing Department
* Primary Manufacturing Operations interface for new technology and new capability projects
* Identifying and Implementing technology to improve safety, quality, efficiency and/or regulatory compliance.
* Support the development and maintenance of strategic planning tools such as the site master plan, long term operating plan, capacity management plan and capital expenditure budget
* Manage cross functional teams to deliver programs on time and on budget.

~BSP

Requirements

Position:
* Expert knowledge of biopharmaceutical manufacturing processes, systems and equipment
* Expert knowledge of electronic manufacturing and quality systems
* Knowledgeable of manufacturing automation systems and their application
* 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 pharmacopea requirements
* Knowledgeable of late stage clinical and commercial manufacturing regulatory requirements and best practices
* Knowledgeable in supply chain operations and business processes
* Possesses strong verbal and written communication skills
* Knowledgeable of troubleshooting/ root cause analysis tools
* Working knowledge of Lean Manufacturing, SixSigma or other continuous improvement tools preferred

Typical experience:
8-10 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors.
6-8 years experience with Masters degree.
3-5 years experience with PhD

Education:
B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study. MBA Prefered. LeanSigma certification prefered.

*LI-MEDI

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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