■ Built and managed a productive group of 27 scientists and engineers that supports manufacturing at multiple sites in achieving >99% on time delivery of products, in addition to meeting all annual goals for safety, quality, and cost. ■ Increased monthly production of CD4 monitoring test by tenfold while reducing production cost by 75%.■ Work with multi-disciplinary members in new product development teams to scale up, validate, transfer and launch >10 new IVD clinical products and genomic products annually.■ Specified and validated automated equipment that minimize repetitive strain injury, and enhance productivity of the manufacturing technicians■ Led Innovation center to develop new production technologies in cell therapy and commercialize novel diagnostic tests that drastically reduce customer reagent and sample preparation time.■ Planned and managed annual continuous improvement projects that resulted in >5% in cost of goods savings.■ Implemented 5S program to organize the manufacturing labs and rooms to maximize the utilization of the limited production space. ■ Responsible for product, processes and equipment compliance with FDA, ISO 13485, WHO and IVDR regulations.

Managed the manufacturing group to achieve quarterly production records in instrument, reagents, and consumables departments while reducing manufacturing costs. ■ Increased quarterly production by 13% to 3.8M units to eliminate backorder situations that had existed for the past 3 quarters while reducing overall manufacturing costs by 14%.■ Scaled up manufacturing process by 200% to meet unplanned seasonal Flu product demand.■ Managed a manufacturing organization of 230 personnel in reagent production, cartridge assembly, reagent filling, kit packaging, instrument assembly, and in-process testing.

Managed the clinical laboratory and manufacturing operation groups to achieve annual growth rate of greater than 100%. ■ Responsible for expanding and growing the laboratory operations testing capacity from 70,000 to 250,000 samples in a two year period resulting in the generation of $50 million in revenue and an establishment of a laboratory organization of 70 laboratory employees.■ Implemented continuous improvement programs in operations and clinical laboratory that rolled out laboratory process efficiency improvements, process automation, and supply chain management that achieved gross profit margin gains from 50% to 64%.

Build up the reagent and instrument manufacturing departments and managed the operation and support services in QA, QC, document control, facility, purchasing, warehousing and customer support.■ Completed development and set up manufacture at OEM supplier of Erenna instrument that consists of lasers, optics, photon detector and mechanical stages used to measure fluorescent signals from Alexa labeled molecules.■ Created and managed the operations group that consisted of production, quality control, purchasing, planning, logistics, manufacturing engineering, shipping and receiving, inventory control, customer support, and complaint and product failure investigation.

Overhauled the manufacturing organization and improved processes to maintain product availability in the market and helped the company change to a research and consultancy business model.■ Developed analytical tools and methods to characterize product properties and implemented process improvements to increase product quality by 300%. Implemented continuous improvement program, monitored key performance indicators and developed response plans to ensure quick responses to operational issues.■ Worked closely with OEM instrument and consumable suppliers to maintain appropriate inventory levels to meet changing product demands.

Led a cross functional team consisting of manufacturing engineering, process engineering, facility engineering, manufacturing and outside engineering groups in equipment setup and experimental design to continually improve and validate machinery and processes.  Generated and revised department procedures and operating documents to enhance FDA and ISO compliance that provided a structured process to implement engineering changes and product enhancements that minimized negative side effects.

Managed the engineering, drafting, facilities and documentation control personnel to meet project timelines and company objectives. Managed health-environmental-safety, maintenance, calibration, warehouse, and facility planning and employee services.

Build up the manufacturing and engineering capabilities for the branched DNA organization.Provided engineering and operational support in the PLA, and PMA FDA submissions for existing and new products. Managed process and facility engineers to support operations and regulatory requirements.

Designed and installed a variety of production equipment and processes that reduce labor cost while improving product quality and production rate.