Willi Huang Email & Phone Number

Walnut, Ca, Us

Waltham, Ma, Us

Waltham, Ma, Us

Own the global supply chain process at Ardelyx, work within a multidisciplinary team, and directly impact strategy and timing of clinical supply chain activities, drug substance manufacturing, and drug product production. Responsible for the strategic clinical and commercial supply chain management, CMO selection and management, 3PL, and project planning & coordination. • Design, lead and implement a comprehensive supply chain strategy at Ardelyx. Manage and improve the Supply & Operations Planning Process at Ardelyx.• Partner with Clinical Operations and other internal stakeholders to create and test clinical supply assumptions.• Act as primary point of contact with 3PL companies and actively manage this relationship to ensure scheduled delivery goals are met.• Execute supply chain direction, and resource requirements sufficient to deliver robust supply solutions• Direct the strategic Supply and Demand Planning efforts.• Drive forecast planning and inventory management of all drug products in the pipeline, both internal and acquired through commercial agreements. In addition, provide Forecast planning and inventory control of all intermediates and final products.• Oversee product purchasing and planning at contract manufacturing and logistic suppliers. Includes establishment and oversight of rolling forecasts for clinical and commercial products, and coordination of clinical packaging, logistics and labeling operations for drug products.• Oversee and manage the supply chain group, and communicate both internally and externally the master production schedules for drug products, including a master production forecast for all strategic partners• Manage key GSC interfaces with Clinical Ops, Commercial Ops, QA, Regulatory Compliance, S&M, and FP&A such that inventory, demands align at both the operational and revenue levels.• Establish and implement inventory policy and materials risk mitigation strategies.• Develop and manage annual operating budgets

 Manages through Global Supply Chain Planning and External Manufacturing department all functional teams to ensure high performance outputs and drives continuous improvement Manages global demand and supply planning to streamline supply chain business process by standardizing demands and supply planning, manufacturing operations processes to sustain process efficiency and effectiveness Led the designs and implementation of global supply network planning business processes and manufacturing capacity planning. At the same time provides scenarios planning for risk mitigations and business opportunity planning.  Collaborates and partners with legal, Regulatory Affairs, Quality Assurance, Technical Service, Sales, and Finance teams to review and negotiate supply agreement, ensure supply chains processes and procedures are followed for each CMO and CPO Directs and oversees Contract Manufacturing and Contract Packaging organization to ensure a smooth technology transfers and ensure communication between all departments and CMO’s partner sites for any supply chain issues and risk mitigation  Prepares and facilitates the monthly Sales and Operations Planning (S&OP) to achieve utmost customer service and financial result Prepares and issues 5-year strategic plan to evaluating cost and business impacts on internal resource capacity, technology transfers, external suppliers and partner alliances Led Global Supply Chain to reduce finished goods inventory of $20M through the improvement of lead time, batch size reduction, campaign size, and performance measurement Provide leadership to Serialization project team ensure successful implementation of serialization for company’s 200+ NDC products in order to meet DSCSA compliance requirements Responsible for the supply chain performance matrix , manage end-to-end value chain planning to support inter company technology transfer Facilitates weekly internal and external manufacturing output performance review

Provide supply chain expertise and leadership with the responsibility of manufacturing and packaging planning, material management, production schedules, resources and capacity planning required for cGMP commercial operations and new product launch (ANDA and NDA) conducted in California, Pennsylvania, and Taiwan. Manages through Global Supply Chain Planning and Material Management department all functional teams (master schedulers, buyer/planner, planning systems) to ensure high performance outputs and drives continuous improvement efforts in area of responsibility and assists these efforts in other areas as needed Leads daily operations planning meeting with manufacturing, QA, QC, Technical Service and Engineering to mitigate delivery risks for critical products to meet customer service objectives Manage new products launch planning and site transfer planning to ensure on-time and on-budget product launch by collaborating with cross-functional teams through supply chain technology transfers Prepares and issues 5-year strategic plan to evaluating cost and business impacts on internal resource capacity, technology transfers, material planning, and major material requirements Responsible for the supply chain performance matrix to ensure internal delivery plan, production plan and scheduling are meeting the Adherence to Plan performance  Member of corporate Quality Council and Technical Operation Continuous Improvement team leading CI programs on business process improvement in responding to operations shortfall and inventory performance Responsible for SAP ERP systems implementation and post implementation continuous improvement regarding supply chain business requirements. Responsible for maintenance of the SAP Master Data and Production Data to ensure accurate supply chain information.  Responsible for establishing and maintaining of supply chains policy and SOP (standard operating procedures) in compliance with cGMP, FDA Regulatory, and SOX

Sunnyvale, Ca, Us

Lead enterprise foundation technology teams using industry best practice and Lean Six Sigma methodology to streamline, design and implement business process for customer support, sustained engineering, root causes analysis, and corrective actions to all business units, ultimately accomplish better customer experiences of using Juniper’s products and services

Norcross, Ga, Usa, Us

Provide business and systems consulting services in Global Demand and Supply Chains using ERP, Lean Six Sigma and continuous process improvement methodology. Re-engineered and led the architecture design and implementation of Global Demand Planning process to collaborate and streamline sales, marketing, finance, demand management and supply operations process resulted in the improvement of forecast accuracy, finished goods inventory reduction, customer service quality of order lead time and on-time delivery for Abbott Diabetes Care manufacturing company Directed and led Lean Six Sigma Black Belt project by implementing DMAIC methodology to a high volume healthcare data service management company

South San Francisco, California, Us

Led large cross-functional teams of 50 professionals (onsite and offshore) and successfully delivered SAP ERP systems with technical and integrated solution, data conversion, system infrastructures, and wireless networks to Global Supply Chain and Product Operations customers. Directed large data organization of 35 professionals to support end-to-end operations intelligence (OI) and business intelligence (BI) data include both master data and transactional data for Genentech’s Commercial Brands Marketing, Managing Care Commercial Operation, Sales Operation and Information Management (SOIM) customers. This includes facility with Siperian (MDM), Commercial Atomic Data System (CADS), Operational Data Store (ODS), Event Management System (Aprimo), Sales Force Automation (SFDC), and Aggregate Spends. Key Accomplishments: • Consistently delivered zero defect SAP applications and data to supply chain customers driving the turnaround of mission-critical operations at crucial point every time • Implemented the first ultra high availability systems with 99.999% uptime solution to BioChem’s MES systems for EBR and eBOM resulting in multi-millions dollars saving on material waste reductions • Initiated Six Sigma SIPOC processes to build Commercial IT Operational Support Model, resulting in reduction of Service Level Agreement (SLA) response time on level 2 support by 50% using a streamlined communication metric• Introduced and led a quality improvement program at key vendor sites which resulted in an overall improvement of data accuracy (98%), on-time delivery (95%), and improved defects from 6000 per million to 25 per million• Reduced production data deployment time 30% by streamlining data process flow and validation procedures resulted in $140K saving each time• Led and delivered a large scale Manufacturing Execution System (MES) to South San Francisco BioChem manufacturing site on schedule and within budget ($24M).

Global Supply Chain Business consulting firm specializing in Pharmaceutical Industries, major clients include Merck & Co. (1996-2003), Johnson & Johnson Ortho-Clinical Diagnostics (2004), Novartis Pharmaceutical Corporation (2005)Managing Director, ERP & Supply Chain SystemsConsulted and partnered with senior level management teams in the supply chain operations, manufacturing, and information technology sectors of global pharmaceutical companies to deliver supply chain best-practice solutions, while developing more than 20 new business processes for Merck Manufacturing Division. Directed a large cross-functional organization for the implementation and M&E support of KBM/Data3 and JDE’s ERP Global Supply Chain systems for 7 of Merck’s chemical manufacturing and distribution sites worldwide (North America, South America, and Asia Pacific); led support organizations to service key operations of Demand Planning, Made-to-Order, Made-to-Stock, Order-to-Cash, Procure-to-Pay, Product Costing, and Warehouse Distributions. Key stakeholder on Change Control Board, ensuring that computer systems meet FDA regulatory compliance (cGMP and 21 CFR Part 11)Key Accomplishments: • Directed business processes reengineering in Foreign Trade Zones for Merck’s Global Business Process & System group; since its inception, this process has resulted in an annual savings of $2M on raw material taxes and cut the lead time for preparing accurate customs documentation from 2 weeks down to 45 minutes.• Directed business process reengineering to improve Electronic Shop Floor Batch Records by integrating quality control procedures with ERP Work Order and Recipe system; this resulted in $6M of savings by eliminating errors, reducing lead time, and streamlining documentation required for regulatory compliance• Directed the design and implementation of CFR 21 Part 11 Electronic Record and Electronic Signature for Merck’s manufacturing system to meet FDA regulatory compliance.

Us

Led division’s MRP II Department with responsibilities of production planning & control, organization change management, and material control for four manufacturing sites. Oversaw $2M budget of IT operations, managed a staff of 15 professionals to support engineered material division users with MRP II system, precious metal cost system, and customer sales system. Oversaw MRP II Implementation and Business Process Reengineering activities to achieve Class-A Manufacturer status by improving On-Time delivery performance, inventory accuracy, customer service excellence, resource planning optimizationKey Accomplishments: • Led a large Business Process Improvement program to reengineer order processing flow, reducing non-value-add steps for Engelhard Corporation’s Catalytic Gauze product; this successfully reduced the number of process steps from 52 to 13 and cut lead time by 80%, resulting in an additional $2M sales per month through capacity increase.• Streamlined Industrial Thermo Couplers shop floor processes by implementing JIT Kanban system, resulting in 30% precious metal inventory reductions equivalent to $250K in savings• Directed the integration project of customer sales system and MRP II sales information architecture to provide on-line product information to the division sales organization and reduce customer response time from 7 days to 2 days.

Woodmead, Gauteng, Za

Manufactures and markets a wide variety of specialty imaging products and services to industrial and commercial customers to meet various print application needsManaged Finishing departments with increasing responsibilities of packaging, rewinding, warehouse, shipping, and receiving operations• Improved productivity by leading improvement committee for the implementation of TQM and Statistical Quality Control in division with guidance from Deming and Conway • Implemented JIT Kanban system on shop floor to meet company goals of on-time delivery, productivity improvement, and quality standards• Designed and developed probabilistic model to monitor and leverage sales forecasts and inventory levels• Designed and developed effective productivity index system to support production planning and scheduling for better customer service

Ms, Operations Research

Bs, Industrial Engineering