Atlanta Metropolitan Area
I am a Head of Data, Digital, and Technology at Takeda Pharmaceutical, a global leader in the pharmaceutical industry. With over 15 years of experience in the Digital Transformation with life sciences domain, I have a proven track record of delivering transformative solutions that integrate operations technology and business systems, optimize manufacturing processes, and ensure compliance with regulatory standards. As a Head of DD&T, I lead the digital transformation programs for manufacturing, operations, and enterprise at Takeda. I manage the technology deployment, infrastructure, network, and cybersecurity operations for plasma derived therapy and lab operations. I also oversee the manufacturing digitization with MES, data historian, and data lake solutions. My goal is to enable site operations optimization with strategic digital initiatives and leadership direction. I leverage my technical expertise, project management skills, and industry knowledge to create value for our clients and stakeholders.
As part of Site leadership team leading Digital Transformation programs for Manufacturing, Operations and Enterprise. Plasma Derived Therapy operations digitalization, technology deployment, infrastructure, network and cybersecurity operations management. Lab operations digitization, with deployment and management of various technologies such as LIMS, Lab Automation. Manufacturing Digitization with MES, Data Historian, Data lake. Site operations optimization with strategic digital initiatives and participation in leadership direction.
I have taken on leadership roles focused on delivering transformative solutions within the pharmaceutical and biotech manufacturing sector. As a leader of the Solution Architect team, I have orchestrated the deployment of SaaS solutions tailored to clinical and commercial operations, driving digitalization across manufacturing and compliance domains. Strategic Leadership: I am overseeing end-to-end deployment and system integration, ensuring product and process maturity. My efforts encompassed fostering internal and external partnerships to enhance customer success. Product Development: Mentoring deployment teams in MES system application functions, compliance design, and multi-site deployments. Technical Leadership: I led integration design, validation, and deployment for MES systems using No-Code, Connector, and Custom integration development. Collaborating with System Integrators, I ensured custom-defined deliveries. System Architecture and Infrastructure: I provided technical and functional leadership, defining software, deployment, and infrastructure architectures. I developed SaaS and PaaS models with custom configurations. Program Delivery: My leadership was integral in deploying MES systems, integrating with ERP and Level 3 systems. I maintained a Quality First approach, upholding data integrity and compliance with 21 CFR P11, ALCOA+, GAMP, and cGxP standards. Program Management: I managed CAPEX/OPEX budgets, conducted strategic analyses, designed project architectures, and developed project support teams, resulting in enhanced ROI and project success. Strategic Architecting: Design of GxP systems, Automation, and Operations Technology roadmaps, aligning with Industry 4.0 principles to ensure compliance, sustainability, and integrated application architecture. People Leadership: As a leader of Solution Architects, I emphasized individual and technical mentorship, fostering leadership development, and facilitating external training opportunities.
Global MES solution rollout and Management: Mylan global MES application solution and implementation of the best practices for manufacturing IT systems. Integration strategy with ERP, Automation, and other Mfg. systems, coordination between manufacturing sites. IT Strategy for successful solution functional and technical. Define and support Automation roadmap for the future growth and opportunity, the orchestration of multi-project environment to optimized delivery at least possible effect to an ongoing manufacturing business. Technical: IT Infrastructure management and strategic development for MES, Data Historian solutions, best practice implementation, disaster recovery plan assessment, and business impact assessment. Data Historian and SCADA system design, development and implementation. Strategic decision making for, optimized business process design with automation strategy towards review by exception. Functional: Business Process Development, optimization of the current business process, strategic partnership within the site to optimize manufacturing and gain excellence in automated manufacturing. SME consultation for Computer system validation for automation and manufacturing IT systems. Change control review for application and business process changes and all scope project delivery. Finance and Management: Vendor selection strategy, Vendor Engagement, and Negotiations, ROI Analysis, Feasibility study, Business Risk assessment. Program Management, Project Portfolio Management, forecasting of the project, CAPEX, and OPEX run sheet deliveries for governance. Achievements: Program Owner of Automation program in Morgantown, WV site. - $8 Million Site Equipment Upgrade, making production floor technology ready. - $700K Data Historian Implementation sitewide. Saving of production cost up to 20% per batch. - $1.8 Million Sitewide MES implementation. Reduction of cycle time up to 30% with technology, execution of Electronic Batch record process.
Werum IT Solution is one of the very well know and leading MES solution provider to global clientele specifically in Pharmaceutical, Biotech, Medical Device and Consumer goods industry that regulated by FDA regulations. Technical support and consulting: MES (Manufacturing Execution System) for Pharmaceutical, Biotech, Medical device manufacturing and related business process clients. Development and deployment of PAS-X MES Software. Overall project management, Validation planning, Disaster Recovery Planning, over all IT infrastructure design and management. Responsibilities and Duties: Project management, Return on investment (ROI) analysis for new projects, project support activities. Process development consultation, Master Batch Record (MBR) development, PAS-X installation, technical support. IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification) testing and validation process development and management. Fit analysis for new projects, proof of concept development, customer requirement analysis and development of the demo system. Communicate client expectation with senior management for project support and schedule. Consultation for industrial expertise in enforcing cGxP quality standard and complains with authority. Development and selection of the COTS and SaaS systems with internal and external vendor meetings and scope development and over all project management with SOX compliance. Support and management of service desk for general support ticket and hyper-care tickets. Knowledge development and mentoring new employees.
Website development at School of management. Job board development, data analysis and bench-marking of Department with other universities. Archive data knowledge management database development at Graduate Studies office. Policy development, operations procedure development for NJIT operations handled by Graduate Studies Office. BS/MS program promotion at NJIT. Back office administration support to Graduate Studies office staff. Event management, document management and meeting scheduling.