Vekarious Barnes

About Vekarious Barnes

EXECUTIVE SUMMARYGlobal Program and Portfolio Leader with 15+ years of experience leading complex pharmaceutical and medical nutrition assets from pre-clinical through commercialization and lifecycle management across FDA, EMA, MHRA, Swissmedic, Health Canada, and TGA jurisdictions.Recognized for establishing governance, portfolio visibility, and cross-functional execution models that enable R&D, Regulatory, Quality, Clinical, CMC, and Commercial teams to deliver high-value assets efficiently. Proven leader of global lifecycle initiatives, marketing authorization transfers, tech transfers, label expansions, and commercialization readiness across sterile, oral solid dose, biologics, and topical platforms.Trusted by executive leadership to manage high-risk, high-visibility programs including billion-dollar brands (Zenpep®), first-in-class therapies (Palforzia®), microbiome therapeutics (VOWST®), and global asset transfers under TSA/ATA structures.CORE LEADERSHIP CAPABILITIES-Global Program & Portfolio Governance (30+ assets)-Lifecycle Management & Label Expansion Strategy-Marketing Authorization Transfers (US/EU/UK/CH)-Cross-Functional Leadership (R&D, Clinical, Regulatory, Quality, CMC, Commercial)-Tech Transfer, IQ/OQ/PQ, Process Validation, Commercial Readiness-IND → NDA/ANDA/BLA → Launch → LCM-Budget Ownership ($2M–$10M+ per program)-Risk Management & Executive Reporting-PMO SOP Development & Portfolio Systems ArchitectureENTERPRISE IMPACT HIGHLIGHTS-Led dissolution of pharma partnership and asset acquisition under TSA/ATA while EMA variation was in progress-Led wastewater root cause investigation for acetone/IPA excursions and implemented CAPA-Designed Lean Six Sigma visual production planning system saving $5M annually-8+ years analytical leadership delivering ICH stability-indicating methods for clinical submissions-Managed program budgets from 2M–10M CHF-Authored PMO SOPs and governance standards for Nestlé Pharma PMO-Led risk governance for high-complexity, high-visibility programs-Built SharePoint-based budget and reporting infrastructure adopted by teams

Experience

1. Senior Program Manager

   KBI Biopharma

   Mar 2026 — Present · Raleigh, NC, US

Education

• Florida State University

  Bachelor of Science - BS

• Wake Forest University School of Business

  Master of Business Administration - MBA

• University of Florida

  Master of Science - MS

• Wake Forest University

  Master of Business Administration - MBA

• South Piedmont Community College

  Lean Six Sigma Green Belt Certification Program