Robert Serra, a Johnson & Johnson certified Black Belt and ISO9000 certified auditor, has a diverse background in analytics, process improvement and compliance that encompasses Biotech, Pharmaceutical and Medical Device industries.  His approach to problem solving is based on a strong foundation of basic technical principles along with analytical skills and the use of statistical data to fully understand the problem before arriving at a forgone conclusion.  He believes that using the right tools and techniques early in the process avoids having to repeat work and thus provides the correct information within the required time thereby reducing wasted man-hours. 

Robert Serra, has degrees in analytical chemistry and mechanical engineering and over 30 years of industrial experience which encompasses product development from formulation through scale-up and finally commercialization of large scale processes.  He fully understands the development cycle and how to transition a development project into a commercial project. He has worked with a number of start-up companies providing guidance and technical support in developing the backbone of the organization as well as the required technical and quality assurance documentation needs.  He is founder of Biopharma Consulting, Inc. and co-founder of QbD Auditing, Inc.  Robert Serra is well known in his professional area of expertise and has spoken on various topics. He has received a number of industry awards.  (For further information, please see full curriculum vitae.)