Provide leadership regarding global business continuity and risk mitigation that is extended from Corporate to all local affiliates in order to achieve global coverage. Drive the enlarged CMO network perimeter at the Global level (EU + the US) for Corporate Products. Responsible for second source CMO scouting and selection, evaluation for marketed products was expanded. Lead point of contact for supply escalation, contract negotiation and renewal, service level KPI monitoring, and external CMO S&OP process ownership. Serves as a business partner for product joint steering committees, operations, and business development activities. Strategically define external manufacturing activities and conduct due diligence. Lead CMO engagements for LCM programs and coordinate with internal stakeholders for technical and quality activity (CMO focused). Ensures flawless acquisition integration with supply chain teams globally.

Oversee the supply chain of the Company’s Product portfolio from manufacture through to the distribution channel. Direct supplier selection and relations, production planning and forecasting, inventory management, distribution, and customer inventory analysis. Serve as the Supply Chain representative on project core teams with duties including sourcing and securing of all clinical trial, investigational product, and API supply, as well as overseeing competitive procurement and vendor review processes for development products selected for the US market. Serves as a member of the Company’s Management Operating Committee. Responsible for procurement and inventory management of marketed and investigational pharmaceutical product lines, through effective management and leadership of the Supply Chain team. Primary functional ownership for the continual improvement in the reliability, security, and long-term stability of the Chiesi USA supply chain. Responsible for all contractual relationships and negotiations with 3rd party manufacturers, packagers, API suppliers, and 3rd party logistics providers. Responsibilities include maintaining supply chain relationships with Parent Company for all manufactured or sub-licensed products, including monthly reporting and achievement of KPIs and procurement of Corporate products. Work closely with the business development, regulatory, drug development, marketing, and corporate accounts departments on the development, CMO sourcing and selection, acquisition, and launching of new products. Responsibilities also include performing supply chain due diligence on asset and/or company acquisition targets. Collaborates with Finance and Marketing to determine the appropriate yearly forecast for each product and build production requirements accordingly. Primary driver Chiesi USA demand management and S&OP process.

Responsible for all aspects of planning, buying, scheduling, capacity planning, materials management and logistics. This includes the deployment of common systems, improved processes and advanced technology to drive continuous improvement in planning, scheduling and supply chain optimization. This position is also responsible to ensure activities of all assigned personnel result in the timely and cost effective processing of orders to insure customer and stakeholder satisfaction. Work with the Business Unit Directors (BUD’s) and Customer Service Manager to develop and implement a site planning and scheduling process that maximizes customer satisfaction, while optimizing cost effectiveness. Work with the Business Unit Directors (BUD’s) and Customer Service Manager to lead an initiative to optimize the site supply chain to reduce cycle time and minimize inventory levels. Develop and implement an appropriate site procurement process that optimizes inventory and working capital and concurrently, links with business development to ensure a process of business recovery of cost changes as appropriate. Working with the Business Development Team, develop innovative supply chain processes that provide market differentiation. Working with the Business Development Team, develop and implement an appropriate process for capacity planning and S&OP. Manage planning function to ensure effective work order/purchase order creation and maintenance. Partner with Global Procurement on the strategic purchasing function in vendor selection and negotiation to obtain most favorable pricing, service, and terms including Central Parts, Tooling, R&M and MRO purchasing. Is responsible for driving performance improvements in the key indicators for supply chain optimization, including MRP effectiveness, schedule adherence, reduced obsolescence and reduced inventory on hand. Manage supplier rating system. Design and uses metrics to improve processes and ensure optimal use of ERP system.

Managed the global cellular immunotherapy scheduling and logistics for clinical manufacturing of multiple products while establishing solid operational groundwork for successful commercial launch and operations efficiency. Managed supply chain functions in support of clinical trial materials (CTM) and oversee production planning, project management, inventory control and policies for CTM and in preparation for commercial manufacturing. Managed supply relationships with internal and external stake holders. Investigate and recommend new and improved planning systems and processes and identify risks in supply chain; recommend mitigation plans to senior management and implement solutions. Ensures policies are established and drives quality improvements and initiatives related to the supply chain management. Manage internal and external communication and logistics regarding batch releases and global dose shipments. Ensure timely and accurate communication of schedules to stakeholders. Work with partners in Manufacturing, Clinical Operations, QA, QC, Materials Management, and external partners for efficient scheduling and timely delivery of products to clinical sites. Manage inventory of work-in-process and finished goods, including working with Clinical and Manufacturing to schedule patient material collections and production of key intermediates on a just-in-time basis. Collaborated with internal and external E-Systems partners to build robust scheduling tools with ERP (SAP) integration. Managed key supplier relationships with partner providing cold chain inventory storage, kit production, and shipping depot services between Argos and clinical sites. Evaluated and developed business alternatives and back-up sourcing for logistics providers to balance risks and costs. Supported the Commercial group in building a Patient Service Center to provide a seamless customer experience for patients and physicians while efficiently allocating manufacturing capacity and logistics.

Drive and act as key point of contact on supply directives and issues with Salix’s key and critical supply matters. Oversee and manage important aspects and processes of a Sales and Operations Plan. Manage day to day logistics of domestic and import/export as required. Proactively provide relationship management for suppliers and drive key elements of product launches. Ensure proper levels of supply from Salix’s global network of manufacturing partners to meet needs of customers and international partners. Manage collaborative working relationship with Salix’s manufacturing network. Meet regularly with partners to ensure performance versus business goals; develop and maintain meaningful metrics for Salix’s partners. Interface with Marketing, Finance, technical, Regulatory and Quality personnel to ensure proper prioritization of projects. Provide analysis and direction within the Sales & Operations Planning process to ensure that decisions related to manufacturing volume are based on current and factual information. Negotiate supply and ensure compliance within existing supply agreements. Assist in the development of advanced planning systems and/or ERP implementation.

Manages outside vendor relationships for the packaging of pharmaceutical products as External Packaging Manager. Conduct performance analysis, create comprehensive reports of findings, and manage production expectations. Deliver business process and performance excellence. Supervised seven direct staff overseeing operations for eight packaging manufacturing production lines. Implemented and managed all costs, delivery, and quality initiatives to meet the demands of sales and forecast groups. Collaborated with planning, procurement, and warehousing departments to obtain materials that meet FDA, DEA, and OSHA regulations. Implemented Lean Six Sigma methodologies to improve product compliance ratios to 98% and increased delivery schedule reliability to 94%. Streamlined production processes and conducted value stream mapping to identify process improvements, increasing production yields by 20%+ for an alcohol dependency rehabilitation product.

Directed and led performance initiatives for upwards of 65 full-time and hourly associates. Determined production schedules and oversaw the P&L. Tracked preventative actions, process reengineering, and lean initiatives. Utilized Access to track production performance and issued recommendations for improvement. Supervised a team of seven associates as Quality Supervisor; oversaw quality assurance efforts for product labeling and managed 2nd shift manufacturing and packaging operations. Served as an analytical resource to maintain cGMP compliance. Designed and developed numerous tracking databases for production efficiency and customer complaints; achieved a manufacturing equipment effectiveness rating of 71%. Led a manufacturing-based team to reduce coating related deviations by 43%.

Worked with large and small volume solutions, and blow, fill, and seal business units to manage the issuance and receipt of components used for production. Supervised seven staff managing materials planning efforts for packaging and manufacturing inventories used by three internal business units. Oversaw automated shipping and receiving operations of commercial, quarantine, and transferable finished products valued at $40 million.