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Guilherme Guimarães de Souza

Senior Manager - Projects R & d Industrial Operations @Daiichi Sankyo Brasil

São Paulo, BR
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2017 — Present

Senior Manager - Projects R & d Industrial Operations @Daiichi Sankyo Brasil

Sao Paulo, BR

Manager in charge of Operations Prj, New Products, Technology Transfer, Development, Engineering and EHS areas:Project Management;CMC (Chemistry, Manufacturing and Controls) evaluation and management;Products life-cycle management, post-approval changes, process improvements;New product development, R&D and Pharmaceutical Technology. Manufacturing equipment definition, purchase and start up;Manufacturing and PackagingTechnology transfer from other sites worldwide;New products feasibility evaluations, Business case, NPV, cost prospection;Member of New Business Development Committee;Due-dilligences and CMO management, prospections, definitions and qualifications.Kaizen Projects Leader - Continuous Improvement and Lean Six Sigma projects;Engineering Projects - infrastructure, construction, refurbishment, capacity increase, Site Master Plan.Technology updates;Area annual budget and Plant CAPEX responsible;Team management of Pharmacists and Engineers;

EDUCATION

2010 — 2010

IME / USP - Daiichi Sankyo Brasil

Estatística Aplicada a Indústria Farmacêutica

2008 — 2009

Pós Graduação - Faculdades Oswaldo Cruz

MBA, Gestão Industrial Farmacêutica

2003 — 2007

Universidade de Alfenas - UNIFENAS

Farmácia Bioquimica Industrial

2017 — 2018

FIA - Fundação Instituto de Administração

Master of Business Administration (MBA), Business Administration, Management and Operations

2011 — 2011

Seta Desenvolvimento Gerencial / Daiichi Sankyo

Green Belt - Lean Six Sigma

SKILLS

21 Cfr Part 11ManufacturingComputer System ValidationProcess ImprovementSterilizationValidationRegulatory AffairsCleaning ValidationR&DClinical TrialsPharmaceutical IndustrySopFdaProduct DevelopmentTechnology TransferR&D OperationsQuality ControlGmpLean ManufacturingBiotechnologyQuality AssuranceQuality SystemProcess SimulationDrug DevelopmentSapRisk AnalysisProject ManagementPharmaceuticsPharmacologyChange ControlCapaSix SigmaEquipment QualificationAseptic ProcessingMicrobiologyManagementRegulatory SubmissionsGamp

ABOUT GUILHERME GUIMARÃES DE SOUZA

Experienced Executive Manager with a demonstrated history of working in the pharmaceuticals industry for 20 years. Skilled in R&D, Supply Chain & Manufacturing Operations, Validation, Technology Transfer and CMC management. Strong management professional with a Master of Business Administration (MBA) focused in Business Administration, Management and Operations from FIA - Fundação Instituto de Administração. Graduated in Pharmacy Biochemistry.

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