James Paraiso

About James Paraiso

Executive professional with over 25 years of Human (Brand and Generic) and Veterinary pharmaceutical experience in developing people, projects and programs to meet and exceed company goals. Proven global ability in strategic and tactical planning for process improvement, product launch, technology transfers and multi-site integration. Areas of expertise and experience in a leadership role are- New Product Introduction for Global market using QbD concepts- Pharmaceutical Technical Services (Internal and External Transfer, Optimization / Remediation of Legacy Products / Scale-up / Reformulation / Alternate Suppliers)- Third Party Product and Project Management with Global CDMOs / CMOs - Validation (Process using Product Lifecycle approach, Continuous Process Monitoring, Cleaning, Computer, Equipment and Critical Utilities)- Manufacturing Technologies:(Solids, Semi-Solid, Liquids, Sterile Solution / Suspension / Lyophilized for Injectable, Transdermal)- Packaging Technologies:(Bottles, Blisters, Pouches, Ampoule, Vials, Pre-Filled Syringe, Serialization)- Statistical Data Analysis:(Products in development, remediation, optimization and CPM)- Regulatory: Technical SME for NDA, ANDA, PAI, GMP Inspection and Other Post Approval Type Submissions (FDA, MHRA, EMA, Health Canada, TGZ, ANVISA)- Quality Systems Management:(Change Controls, Deviation Resolutions, CAPAs, APRs, Audits)- Team building and development - Multisite integration for harmonization and upgrade of quality and business systems

Experience

1. Senior Director Product Commercialization

   Serán BioScience

   Feb 2022 — Present · Bend, OR, US

   Key leadership role to support building commercial manufacturing capability for human pharmaceutical products using proprietary technologies

Education

• Mapúa University

  BS, Industrial Engineering

  1979 — 1984

Skills

• Project Management
• Regulatory Requirements
• Regulatory Affairs
• Pharmaceutics
• Design of Experiments
• Manufacturing
• Quality Management
• 21 Cfr Part 11
• Generic Programming
• Process Optimization
• Quality System
• V&V
• Document Management
• Gamp
• Cleaning Validation
• CRO
• Process Improvement
• Technology Transfer
• Glp
• Validation
• Six Sigma
• Product Launch
• Gxp
• Quality Auditing
• R&D
• Quality Control
• Gmp
• Management
• Medical Devices
• Capa
• Program Management
• Cross-Functional Team Leadership
• Regulatory Submissions
• Biotechnology
• Process Engineering
• Pharmaceutical Industry
• Sop
• Fda
• Continuous Improvement
• Quality Assurance