Suzanne Hladun
Owner @Stonehouse Consulting
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WORK HISTORY
Owner @Stonehouse Consulting
Frederick, MD
With a strong background in Manufacturing, Program Management and Quality in the biotechnology industry, Stonehouse Consulting offers a range of Program and Project Management services with an emphasis on a holistic approach to product realization within the constraints of Design Control. Clients include both small organizations and Fortune 500 companies- Have successfully planned and executed technical transfer of drug substance manufacture into new facility utilizing resources across four continents in both a remote and onsite environment- Designed and managed global program to reduce cycle time for biologics product launch including definition and creation of program project teams, goals and metrics. 15% overall reduction realized within a 12 month timeframe- Planned and implemented global forecasting and inventory management systems for reusable components- Designed and established standardized system for generation and management of customer service contracts for biologics products- Generated contingency plan for biologics manufacturing strategy.Areas of Expertise- Program Management support for RUO products, Class II medical devices and drug substances- Project Management support including stakeholder and project definition, scheduling and execution with emphasis on creation of accessible project management tools and tracking mechanisms- Process improvement through planned change processes within the constraints of Design Control- Audit against existing procedures to ensure compliance with internal systems- Technical document and report writing to summarize program and project management activities.
EDUCATION
Hood College
MBA, Management
Virginia Tech
MS, Biochemistry
Virginia Tech
Bachelor of Science (BS), Biochemistry
SKILLS
ABOUT SUZANNE HLADUN
Biotechnology professional with a wide range of experience in manufacturing, Sales & Operations Planning, project management, program management, quality control, quality assurance, GMP compliance and commercial development positions. I have enjoyed my experiences in both large corporate environments and entrepreneurial start ups. Have worked in remote roles, coordinating program efforts across four continents as well as hybrid in-office/remote roles for over ten years. Specialties: Performance management for large production groups, product development and realization program management, project management, development of metrics, quality assurance in GMP environment, market research, strategic planning, technical problem resolution, 5S and Lean Projects, managing production activities, Sales & Operations Planning; Lean Six Sigma Green Belt
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