William Black

Background

About William Black

SUMMARYSenior/Principal Level Project Manager or Senior/Principal Level Quality Engineer or Manager with complementary blend of technical knowledge, manufacturing experience, Quality Engineering and managerial skills to organize and manage projects or activities to successful completion. Expertise in managing, organizing, analyzing, communicating, design control, failure investigations (CAPA) and risk mitigation, Quality System design, and leading small and large teams. Proven success in product development, project management, compliance, licensure, risk mitigation for manufacturing profitable products. Skilled in development of reagents on instrumentation systems and regulatory submissions. •Developed blood screening assay to detect antibodies to HIV-1, HIV-2 and HIV-1 group O on automated FDA approved instrument with projected revenue of $65M. Managed cross-functional team of 50-80 members. Executed and managed manufacturability improvements, Design Verification, external Design Validation (clinicals), and submission of Investigation New Drug (IND) to Food and Drug Administration (FDA). Submitted Biologics License Amendment (BLA) to FDA in July 2008 and the product was approved by FDA in September of 2009.•Developed and implemented Abbott Diagnostics Division's electronic Design Control System to meet divisional directive of conformity with Quality System regulations. •Developed two microparticle based HIV-1/HIV-2 assays on automated instrumentation systems to gain incremental diagnostic and blood screening HIV testing business. Transferred both products to an offshore manufacturing site (Germany) and completed international regulatory submissions to obtain approval by non-US regulatory agencies.Specialties: Project ManagementProject Charters, Plans, Timelines and BudgetsDesign Control (User Needs, Product Requirements, Design Requirements, dFMEA, pFMEA, Control PlansImmunoassay/Molecular Diagnostics DevelopmentHepatitis/Retrovirology-Human Immunodeficiency Virus (HIV)Large & Small Scale Solution/Reagent/Drug Development, Formulation & ManufacturingSterile Filling, BFS TechnologyQuality Systems Design & RegulationRisk Mitigation & Risk ManagementFailure Investigations (Root Cause) and CAPA