Speaker

Gary LeDoux

Manufacturing Systems Program Manager, Vericel Inc.

Driven by a passion for technology and innovation, I specialize in leading complex IT Program & Project Management initiatives within the life sciences, biotech, and manufacturing sectors. My expertise lies in Manufacturing Execution Systems (MES), process automation, GxP compliance, and cross-functional team leadership, ensuring seamless execution of enterprise-level solutions.

With a strategic mindset and a hands-on approach, I have successfully managed large-scale systems integrations, vendor negotiations, and process improvement initiatives, consistently driving operational excellence and efficiency. My ability to bridge the gap between business needs and technical solutions has enabled organizations to implement cutting-edge digital transformations while maintaining regulatory compliance.

Key Expertise:
✅ IT Program & Project Management – Agile | Waterfall | SDLC | Risk & Stakeholder Management
✅ Manufacturing Execution Systems (MES) – Siemens OpCenter | Werum PAS-X | IBM Maximo | LIMS
✅ GxP Compliance & Validation – SOP Adherence | System Testing | Process Automation
✅ Systems Integration & Process Optimization – ERP | QMS | PI Historian | Lean Six Sigma
✅ Leadership & Collaboration – Vendor Management | Executive Reporting | Team Development

Career Highlights:
🔹 Amgen: Led key GxP-compliant Werum PAS-X MES implementations, a high-impact project that laid the foundation for multiple global initiatives. Recognized for delivering solutions that streamlined manufacturing and scheduling.
🔹 Pfizer | Seattle Genetics: Managed projects supporting biologics manufacturing expansion, including BAS, MES, and CMMS system integration, ensuring enterprise-wide alignment.
🔹 Gilead | Kite Pharma: Spearheaded the deployment of Benchling cloud-based R&D platform, enabling scientists to accelerate drug development.
🔹 Demant | Oticon: Drove regulatory compliance projects and led business process re-engineering efforts for new product launches.
🔹 Vericel Corporation: Currently overseeing MES system architecture, maintenance, and continuous improvement for a cell therapy & device manufacturer.

I am always open to connecting with like-minded professionals, discussing emerging technologies, and exploring opportunities to drive digital transformation in regulated industries. Let’s connect!

Company

Vericel Inc.

Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in biology with medical technologies, resulting in a highly differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. We currently market two autologous cell therapy products and one specialty biologic product in the United States. Personal integrity, teamwork, collaboration, and innovative technology are the foundations of our work. We seek to practice transparency in our clinical trials and research, and in our relationships with each other, our patients, and the investors who support us.