Kevin Doan Email and Phone Number

Engineering and technical operations within the biotechnology industry to support a wide range of activities in the development, manufacturing, and quality assurance of therapeutic drug products.(1) GMP Site Planning and Design - Involved in programming and designing manufacturing facilities for various biotechnological processes such as Cell/Gene Therapy, Viral Vector, mRNA, (mAB), and Oligonucleotides. (2) GMP Equipment and Critical Utilities Lifecycle Management - Supported the entire lifecycle of GMP equipment and critical utilities, from design and retrofitting to startup, qualification, integration, and ongoing asset management. (3) GMP Operations and Product Lifecycle Management - Provided technical support for GMP operations throughout the product lifecycle, including process characterization (CPPs), creation and management of GMP documents (SOPs, WKIs, batch records), design of single-use consumables for fluid management, and implementing process monitoring systems to ensure product quality and compliance.(4) Technical Operations Support - Provided technical and logistical support for various activities such as Technology Transfer, GMP readiness assessments, process change initiatives, Change Controls, managing Quality Events and CAPAs.Skillsets includes:a. Single-use Technologiesb. Technical breadth with Biologics, VV, mRNA, Cell Therapies processes and equipmentc. Engineering industry standards and best practices d. Process development and characterizatione. Project managementf. cGMP and Quality Systems