JESUS GUARDIA

Strategic manufacturing leader with robust background in directing and managing large-scale operations, consistently driving success through strategic planning and execution with 21+ years of experience in cGMP operations, vaccine manufacturing, and CDMO scale-ups. Proven track record of leading cross-functional teams, launching new facilities, and optimizing end-to-end operations. Expert in aligning technical execution with regulatory standards and business goals. Skilled in tech transfer, quality systems, and continuous improvement. Successfully navigated FDA, EMA, and global audits. Committed to making meaningful contributions and advancing organizational goals.

CDMO Success at CBM & SK Pharmteco

• Led operational readiness and GMP production launch of viral vector and plasmid manufacturing facilities.
• Spearheaded end-to-end supply chain planning and vendor qualification to ensure just-in-time readiness.
• Implemented cost reduction strategies that improved margin and reduced waste by over 20%.
• Established KPI tracking and review systems that improved on-time delivery and batch release by 30%.

Sanofi Pasteur – Viral & Bacterial Vaccine Manufacturing

• Oversaw production of viral and bacterial vaccine platforms with full FDA and EMA compliance.
• Reduced deviations by 40% via proactive CAPA systems and targeted personnel training.
• Improved throughput by 25% through Lean initiatives and production planning refinements.
• Led root cause investigations and audit readiness efforts during successful multi-agency inspections.