Mark J. Kapeckas Sanofi Biologics

Collaboration and passionate sharing of solutions are woven into Mark Kapeckas’ fabric.  There are too many patients to serve, and unmet medical needs to work in a less efficient way.  Mark Kapeckas’ career spans the fields of traditional pharmaceuticals, electronic materials, contract manufacturing, and biologics.  Roles have included positions in R&D for test methods and new products, Project and Program Management, Quality Control, Quality Assurance, Quality Engineering.  Mark has focused this unique experiential perspective on Biologics Quality for the past 10 years.  Mark currently leads several global initiatives within the Sanofi Biologics Quality organization.  Relevant micro-focused leadership roles include the Sanofi Global Working Group and Quality Commission responsible for all aspects of Low Endotoxin Recovery (LER).  Also head of the Micro Test Method Lifecycle Management Group globally, Mark drives continuous improvement of micro testing and compliance globally.  Externally, Mark is an active member of the BioPhorum Operations Group (BPOG) Rapid and Reliable Micro Methods sub-team.