Manufacturing Innovation Specialist Manufacturing - Frederick, MD at Geebo

Manufacturing Innovation Specialist

Company Name:
ADP The RightThing
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.
Requirements:
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.
Lean Six Sigma certification prefered.Estimated Salary: $20 to $28 per hour based on qualifications.

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