Ajay Gupta

A critical role managing Third Party Manufacturing Operations of BinaxNOW OTC, eMed and Commercial Antigen tests for Covid-19. Direct range of functions include selection of TPMs who meet the criteria to successfully build product per Abbott’s specifications, Production line layouts, process validations, selection of new technologies for cycle time cost reduction and efficiency improvements, strategizing long-term goals and process improvement projects. Leading network wide implementation of design changes; managing cross functional team effort for uninterrupted transition ensuring regulatory compliance and product requirements. Achievements/Tasks - Managing scale up of BinaxNOW tests from 3 million a month to over 70 million a month in less than 4 months; led selection of new TPMs while guiding them through hiring, line setups, equipment selection, and validations to ensure that growing commercial demand was met monthly. - Lead multiple Request for Proposal (RFP) processes, launch road maps, capabilities, and strategic plans. - Create executive summary and project trackers for product brand leads to communicate updates. - Managing two of the largest reagent ampoule manufacturers using Blow Fill Seal (BFS) technology in the country for capacity, schedule, production, and supply of 60+ million units per month. - Managed relationship between various Abbott functions and the TPMs for change control, engineering, quality assurance, investigations and CAPAs, technology selection, continuous improvement projects. - Lead quarterly business reviews for the TPMs, reviewing multiple tracked metrics related to performance and identifying process improvement and GMI opportunities. - Work with cross functional teams; engineering, quality, logistics; to optimize overall process flow for total ownership cost and identify/propose cost reduction opportunities. - Lead multiple projects concurrently for new product launches as well as change driven projects for FDA compliance.

A highly visible managerial role as a lead engineer and program manager for mid to high volume consumables for Abbott’s Diagnostics Division. Direct range of functions from ensuring design meets the product requirements, product and production equipment design reviews, selection of new technologies, automation, packaging, and other manufacturing/assembly operations. Strategizing long-term corporate goals to leading cost and process improvement projects. Managing design changes and leading Design Verification/Validation activities to ensure regulatory compliance and user needs. Achievements/Tasks - Lead programs for on-market product changes, automation, packaging improvements and plastic consumables across multiple sites in North America and Europe. - Business process owner of the largest consumable (Reaction Vessels) for ADD as lead engineer and Program Manager. Manage the supplier for quality, capacity, supply chain, cost improvement and process improvement projects as well as act as SME during production issues and customer complaints / investigations. Lead production scale up projects (for existing suppliers as well as risk mitigation with alternate supplier) from capital requests, equipment purchases, validation, and implementation. - Managed and served as project lead and engineer for the development, qualification and launch of Alinity (hematology) consumables - Managed all aspects of project working with R&D teams on Alinity platform (various diagnostics instruments for Immunoassays, clinical chemistry, blood screening) for consumables designing, prototyping, developing technologies supplier selection and production setup to best meet functional and user requirements. - Realized division Gross Margin Improvement targets over the years (>$2 million annually) through technology enhancements on multiple consumables. - Led international and domestic product transfer projects to mitigate supply chain risks.

Provide engineering, project management, and technical expertise to guide internal/external engineering functions in a highly regulated environment. Direct range of functions from ensuring FDA compliance in all manufacturing processes, strategizing long-term corporate goals to leading improvement projects. Coordinate with corporate leadership to identify areas within the site for improvement and cost-control initiatives. Mentor and direct team of 14 engineers, programmers, and designers, facilitating on-spec product development and delivering timely product launches. Manage change control and validate processes in conjunction with customers; serve on change control board to analyze impact on processes and assess risk. Monitor resource utilization and determine equipment selection by building a business case and creating capital equipment requests for new technologies. Achievements/Tasks - Directed team of sustaining engineers to innovate and implement enterprise-wide process improvement efforts aimed at reducing cost and boosting quality. - Reorganized engineering department to fully align with functional organization, including formalizing knowledge base, increasing accountability, and providing coaching to enhance skill set. - Led new product design and development projects for multiple sites within the organization. - Coordinate activities at supplier, corporate and internal manufacturing sites - Realized cost savings by implementing lean flow and process improvement. Initiated site wide cycle time improvement program. - Increased productivity and mitigated customer complaints by incorporating DMAIC and DFSS approaches. - Worked with suppliers and teams internally and at a global level to competently troubleshoot process and design related issues. Collaborated with quality department to successfully complete multiple Corrective and Preventive Actions. - Decreased Time to Delivery with effective management of process improvement initiatives.

In this multi-functional role, part of engineering design and quality teams through full method of design from concept to production. Acted as point person for regulating the design, manufacturing, and processing phases, and implemented corrective and preventative actions to enhance the manufacturing process. DESIGN ENGINEER Designed injection molds for medical industry for packaging and testing needs, needle assemblies, hubs and syringes. Selection of right resin for the part (right grade of mostly Nylon, HDPE, LDPE, PP etc.) with the development team. PROCESS ENGINEER Created process drawings and models, defined metrology methodology to help manufacture mold parts per the drawings. Designed manufacturing processes and created setup prints for various operations. Worked with development team to incorporate any changes. PROJECT MANAGER Strategized with development team on new product design, development, and launch, functioning at a senior level in fine-tuning product designs and cultivating customer relationships. Supported ongoing engineering product production while managing change control and executing process validations. Achievements/Tasks - Produced globally used needle safety hub during H1B outbreak by successfully managing project from concept to production. - Reduced the incident of design defects by transitioning from 2D to 3D modeling process of design. - Key contributor in speeding up processing and decreasing costs by programming CNC and CAM systems. - Managed spare components of the molds based on criticality and lead times. Also led mold transfer projects.