Chris Hanff is an accomplished BioPharma senior leader who founded
6Hats Program Management atop more than a quarter‑century of experience spanning early R&D and clinical phases through scale-up and commercial manufacturing, through quality management and third-party oversight to shipping validation, plus consulting and program management.

Chris has been a key player (notably with Millipore Sigma, Johnson & Johnson, Boehringer‑Ingelheim, Concordia ValSource, Regeneron, Kite Pharma (Gilead), Merck & Co., Mallinckrodt, Athersys, Summation Bio, ZWI Therapeutics, and more) in suite start-up, tech transfer, new product commercialization projects, and consent decree remediation — including over three dozen regulatory inspections. He has a keen vision to architect near term solutions while simultaneously scouting a path for long term success, leading his teams to be right-first-time and cost‑effective in bringing products to market that protect health.

Leveraging his lengthy operational and commercial BioPharma experience, Chris intersects Ideation, New Product Commercialization, Quality, and Strategy, to bring insights for many BioPharma companies related to M&A and for Program Management services. Chris has recent successes in Program & Alliance Management for multiple international programs valued over $100 million USD, where he led highly technical, global teams assuring the Technical and Quality parameters of a first-of-its-kind Cell Therapy. Also, has kicked off and led program management for multiple early startups developing novel delivery technologies for therapeutic proteins, and separately, for nonviral delivery of nucleic acids.

Chris has expertise in Quality Risk Management, and has built QRM programs, developed and provided QRM facilitator training, including leading myriad risk exercises, and has published on topics leveraging risk management and risk-based thinking. Chris is an ASQ Certified Manager of Quality/ Organizational Excellence and holds a B.S. in Biology from Truman State University.