Tom Cunningham
Director Commercial Manufacturing @Sumitomo Pharma America, Inc.
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WORK HISTORY
Director Commercial Manufacturing @Sumitomo Pharma America, Inc.
Brisbane, CA, US
Coordinate and oversee manufacture of numerous RSM and API sites globally in support of commercial products and development compounds. Drive continuous improvement in process chemistry, unit operations, and project management. Align multiple product launches related to prior approvals (global regulatory) and significant changes (PAS, MAA Variations) in order to incorporate commercial process improvements with regulatory submission cycles.
EDUCATION
California State University-Dominguez Hills
Master of Science - MS, Quality Assurance
University of Louisville
Bachelor's degree, Chemical Engineering
ABOUT TOM CUNNINGHAM
Lean 6σ Black Belt with extensive experience in the following areas:Pharmaceutical process design, scale-up, validation, commercialization, launch, optimization. Dynamic engineering professional with experience in pharmaceutical API manufacturing; small molecule, fermentation, formulation/tableting, operations management, polymer manufacturing, pharmaceutical project and process engineering management, quality assurance, lean & six sigma, large CAPEX project management, digitalization, business intelligence solutions, and visual management infrastructures. Expertise in root cause investigation, mining and analyzing data to define business requirements and priorities; creating process/business metrics, statistical analyses and other decision-making tools; leading data-modeling and process-mapping initiatives; designing/re-engineering processes, optimizing workflows and technology solutions for manufacturing systems and networks. Proven ability to lead seamless implementations for projects and deliver next-generation technical solutions improving compliance, revenues, margins and organizational productivity.
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