
Welcome to HartEdge BioOps Consulting LLC
We specialize in driving performance within the biopharma sector and we deliver on productivity improvements, operational optimization, leadership assessment and development, and visual management concepts. Whether you're embarking on a greenfield project or striving to improve, HartEdge is equipped to support you from facility startup through ops and sustainability. We ensure success by providing end-to-end management oversight or support across manufacturing, quality, supply chain management, and more.
Services
Startup and Operational Readiness
- Facility Startup Guidance and Support - CQV - Operational Readiness - Project Oversight/Sponsorship
Operations and Quality Optimization
- OpEx Support - Visual Management - Dashboards for KPIs - Lessons Learned Concept - QMS Asssessment and Improvement Planning - QMR Improvement
Leadership and Staff Performance Improvement
- Leadership Assesment and Improvement Planning - Accountability Guidance - Performance Management (2 way) - Leadership and Staff Expectations Concept
About Chuck Hart
Owner Chuck Hart brings his unique view and style into operational excellence, visual management, accountability and ownership, transformational transparency, operational leadership, and continuous improvement. He has developed and gives guidance on the AEIOU of Leadership concept. His 3+ decades in the Biopharma industry and diverse leadership background give him a competitive edge in understanding and implementing operational best practices. Allow him to make your team better and he will deliver.
At HartEdge, we provide biopharma operations and leadership consulting, dedicated to driving operational success through productivity improvements, optimization strategies, and leadership innovation. Call us to deliver Leadership Assessment, Development, and Team Building; QMS System Assessment and Optimization; Facility Startup and Operational Readiness and Excellence; Facility Leadership and Support; Training and Mentoring Programs. We'll provide site support for efficient and compliant operations.
About HartEdge
Testimonials

I’ve known Chuck for over 30 years, and I can confidently say he is one of the most capable, results-driven leaders in the biopharma industry. His strategic mindset, combined with a hands-on approach, consistently delivers transformative results. As a consultant, Chuck brings that dedication, insight, and leadership that made him successful throughout his career. Any organization seeking to enhance ops efficiency, scale operations, or tackle challenging initiatives will find an invaluable partner in HartEdge
Anthony Rotunno - SVP/GM and Site Head, OmniaBio

Chuck’s leadership and operational expertise were pivotal in assisting us in operations transformation. His ability to drive work efficiency and to lead cross-functional initiatives with innovative ideas for improvement resulted in a significant boost in capability and strengthened confidence in our partner CDMO. Chuck and HartEdge won't just deliver results – he will build a culture of excellence through transparency, accountability, and creativity rarely seen in industry.
Lance Holland - Senior Director of External DP Manufacturing, bluebird bio

Working with Chuck has been a game-changer for our business. His unparalleled expertise in biopharmaceutical operations and his strategic insight into cleanroom management have not only helped in elevating the services we provide but have also strengthened our ability to meet the stringent demands of our cleanroom clients. I have enjoyed partnering with him.
Claudia L. Goddiess President/CEO of APEX Building Services

Working with HartEdge was a game-changer for our startup. Their expertise in both greenfield and brownfield projects made all the difference.
David Lee
Contact us and allow us to give you the HartEdge!
Business Hours
- Mon - Fri
- -
- Sat - Sun
- Closed
12760 Hibiscus Ave, Seminole, FL 33776, United States
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