Michael D. Smith Email & Phone Number

Highly experienced technical and people leader with experience leading manufacturing, QC, process development and manufacturing sciences teams. Technical core competencies include scale ups, process development, new product introductions, technology transfers, CMO/CRO projects (working with companies like Roche, Beckman, Promega, Qiagen, AMRI, ACME Bio, CiDRA, Argonaut, MyChem and more), project management and product line transfers. Experienced user of multiple ERP and quality systems in both pharmaceutical and biotechnology environments. Experience in manufacturing products that meet several quality standards including ISO9001, ISO13485:2016, GMP, IVD and ISO18385. Experience in manufacturing precision oncology diagnostic kits for use in CAP/CLIA Laboratories.• Extensive experience with operation systems including SAP, Agile (personally trained to PC OCA level), Trackwise and e-Services.• Responsible for AOP planning including Op Ex, Cap Ex, compensation, outside services, discretionary spending and materials and supplies. Responsible for developing yearly strategies and goals for all work centers and employees. Responsible for developing key process indicators (KPI's) for all areas.• Responsible for executing on lean manufacturing initiatives and productivity projects. • Have served as Project Manager and pitch/catch lead for a site-to-site relocation of a chemical manufacturing work center including planning and build out of facilities. • Have served as Project Manager for a site-to-site product line transfer in addition to my daily responsibilities as a Manufacturing Leader. • Extensive experience in Process Excellence and Design for Six Sigma. Related skills include statistical analysis and Design of Experiments. Have conducted measurement systems analyses, capability studies, implemented control charting and done comparative statistical analysis (ANOVA).

Listed skills include Biotechnology, Protein Chemistry, Dna Sequencing, Pcr, and 32 others.