Stephen Futchko

About Stephen Futchko

Senior Operations and Quality leader with 25+ years of experience pharmaceutical and bio-tech organizations, supporting clinical and commercial manufacturing. I specialize in technical operations, compliance execution, and risk-based decision making in regulated environments. I am known for driving process improvements that strengthen inspection readiness, operational reliability, and cross-functional execution. My approach is practical and data driven, with a focus on solving complex quality and manufacturing issues while enabling scale and on-time delivery. Core competencies:• Process Improvement & Lean Methodologies • Budget & Financial Management• Cross-Functional Leadership & Team Development• Analytical & Problem-Solving Skills • Supply Chain & Inventory Optimization • Project Management & Strategic Initiatives Open to senior Technical Operations or Quality leadership roles within pharma and biotech companies focused on execution excellence.

Experience

1. Consultant Biopharmaceutical and Pharmaceutical

   GLG

   Jan 2025 — Present

   Provide expert advisory support to pharmaceutical and biotech clients on manufacturing operations, process improvement, and execution strategy. Advise on operations efficiency, compliance considerations, and scalable manufacturing practices across clinical and commercial environments.

Education

• Lebanon Valley College

  Bachelor of Science - (BS)

Skills

• Gcp
• Biopharmaceuticals
• Glp
• Medical Devices
• Capa
• Quality System
• V&V
• Biotechnology
• Protein Purification
• Change Control
• Vaccines
• Cell Culture
• Life Sciences
• Pharmaceutical Industry
• Sop
• Fda
• Good Laboratory Practice (Glp)
• Technology Transfer
• Computer System Validation
• Gxp
• Aseptic Processing
• Validation
• Gmp
• Regulatory Affairs
• Lifesciences
• Purification
• 21 Cfr Part 11
• Lims