Jacob Mani

About Jacob Mani

Highly motivated Dynamic and Results Oriented Supply Chain Professional, Project Manager / PMO lead and Team Builder with excellent Communication, Managerial, Mergers & Acquisition, Life Sciences, Finance, Pharmaceutical Business Processes, Pharmaceutical Supply Chain and Manufacturing Operational Excellence, Chemical Industry Business Processes, Flavors, Fragrance & Ingredients Business Process, Manufacturing Plant Operations and Systems ERP (SAP, Oracle, BPCS) skills. Project Engineering (including plant design, field construction, validation, commissioning and start-up).Successful proven track record in managing Engineering, Operations and IT projects requiring Software Validation in FDA regulated and cGMP regulated environments utilizing Project Management Framework (Waterfall and Agile) and Product Lifecycle Management practices for small and large scale domestic and worldwide projects in highly matrixed organizations.Agile methods - Scrum (Scrum Master), XP, Kanban, Software Development Life Cycle used to manage global projects at worldwide plant sites. Proven experience in Bio Pharma, Life Sciences, Healthcare, Medical Device and Chemical industries in the areas of Manufacturing, Supply Chain, Quality Systems, quality control/laboratory, quality assurance, regulatory, product safety, compliance, corporate/operations, and information technology. Other experiences include Manufacturing Plant Process, Business Process Re-Engineering, Process Control Design / Engineering, Validation, Programming / field start-up of Distributed Control Systems, Project Engineering (including $3M to $500 M design, field construction, validation, commissioning and start-up) of Chemical and Pharmaceutical Parenteral, Bulk Synthesis & Finishing Plants. Knowledge of Oral Solid Dosage, Parenteral – Biologics and R&D, Medical Device and Pharma business processes.PMP ® #18•••15, PMI-ACP ® #21•••50, Scrum Master ®, Six Sigma ®, BRMP ® #02••••••01-DDYB, ITIL ® #GR75•••••16JM

Experience

1. Head Distribution Chain and Enterprise Systems

   UroGen Pharma

   Sep 2023 — Present · Princeton, NJ, US

Education

• Cornell University

  Master's degree, Mechanical Engineering

• Bayero University - Faculty of Technology

  Bachelor of Mechanical Engineering (B.Eng), Mechanical Engineering

• Cornell University - Sibley School of Mechanical and Aerospace Engineering

  Master of Mechanical Engineering (M. Eng), Cornell Manufacturing Engineering Productivity Program, Mechanical / Manufacturing Engineering

• Yale University - Chemical Engineering Graduate School

  Advanced Process Control Post Graduate Cerification, Process Control Engineering

• Stevens Institute of Technology - Wesley Howe School of Management

  Master of Science in Information Management - 95% course work completed, Management Information Systems and Services

Skills

• Medical Devices
• Oncology
• Pharmaceutical Industry
• Fda
• Biotechnology
• Six Sigma
• Quality System
• Supply Chain
• Clinical Development
• Sales Effectiveness
• Drug Development
• Biopharmaceuticals
• Sap Products
• Market Access
• Project Management
• Gmp
• Regulatory Affairs
• Lifesciences
• Sap
• Change Management
• Clinical Trials
• Manufacturing
• Cross-Functional Team Leadership
• Operational Excellence
• Quality Assurance
• Erp
• Validation
• Change Control
• Technology Transfer
• Business Process
• Start-Ups
• 21 Cfr Part 11