Joseph A. Email & Phone Number

Experienced Manufacturing Specialist and Senior Project Manager with a demonstrated history of working in the biotechnology industry.Project Management work, serving as the project manager for multiple capital expendituresprojects with a high level of visibility, running presentations and influencing at the departmentallevel and working with CMOs and vendors.Supported and participated in multiple Regulatory Inspections from the FDA, EMEA, Japan,Turkey, and Korea.Experience working in, owning, developing metrics/business tools for, and driving remediation and KPI improvement across multiple Quality and Operational Systems in a Consent Decree (CD) environment, including Inventory, Material Master Data, Cycle Counting, Forecasting, and Labeling.Successfully led the implementation of a fully Part 11 compliant, validated inventory tracking andquality system at a manufacturing facility with a $1 million daily throughput.Skilled in assisting with non-conformance investigations and performing root cause analysis,CAPA development, and Change Control, specializing in matters regarding inventory, ordering,and material control.Doubled Capacity modeling from ~20 to ~40 completed runs per year while at Uniqure.Created yearly savings of $2.25 million at Sanofi/Genzyme.