Executive-level consultant with real-world experience. Manage international projects or solve technical, operational, regulatory and financial problems. Optimum Development Technologies, LLC California State University - East Bay Ellicott City, Maryland 500+ 500+ connections Les Johnson has over 35 years experience in the pharmaceutical industry, specializing in all aspects of the development, manufacturing, quality, regulatory and logistic of biologics, cellular therapies, drugs and devices. Les has a broad range of experience in Bio and Cellular Products and has held senior (up to VP) positions in Development, Quality, Engineering, Manufacturing and Operations at such companies as Bayer (New Technologies), Baxter (Plant Manager), RRD International (Senior Advisor), Progenitor Cell Therapeutics (Stem Cell/Cellular Vaccine Products), Cambrex (Commercial Operations) and Celsis (VP Products Division). He also has significant experience as a consultant, having been the Senior Consultant for Technology and Operations at Biologics Consulting Group, Salamandra and RRD. He has extensive experience as an Independent Consultant. He has provided Regulatory, Quality, Manufacturing, Project Management, interim COO and Commercialization assistance to such clients as The Gates Foundation, Prima BioMed, Virxsys, Merck, GSK, LG Bio, Astellas, Dipexium and Serum Institute of India. Specialties: Manage product developers/sponsors and contract service providers - In Person Build and Manage Quality Systems -appropriate for product status Provide embedded operational, quality, project management and scientific assistance Provide financial and process modeling services - key tools in critical decision making Prepare, deliver and defend regulatory submission to regulatory agencies Perform vendor qualifications, mock site inspections, due diligence assessments, quality agreements and man-in-plant services Investigate and resolve deviations and out-of-specification results Manage validations from individual assays through entire manufact