Tim Roberts, Mba, Ctsc, Cscp, Cltd, Lssgb, Scor-P Email & Phone Number

Needham, Massachusetts

Provide Supply Chain Transformation to exceed business goals and objectives. Client project(s) include: Benchmarking, Evaluation, Transformation, Restructuring and Implementation of Clinical and Commercial Supply Chain Operational Improvement, ERP advisory. Also, provide unblinded CMC/Clinical Supply/Clinical QA for start up clients. SC&L 3PL Consultant (Alkermes, Plc) Identify opportunities and introduce best practices 3PL, for a future compliant , sustainable, and effective process. Partner with such internal functions as Supply Chain, Finance, Trade, Contract Operations, Contracts and Pricing, Validation and Quality to define opportunities. Supply Chain Lead (Imvax) - Device Program Lead for complex, novel device development, design verification, production with a global multinational device manufacturer. Lead drug and device clinical supply forecasting, planning, and overall supply management for Phase 2b clinical program and all associated drug/device development supply needs. Led contracts and scope review, technical evaluation of design, development, forecasting, planning, scheduling, manufacturing, drug/device sterilization strategy to meet product release requirements for clinical device and drug production with CDMO’s.Promoted to : Clinical Supply Chain Lead/ from Associate Director, CMC Project Management (Corbus Pharmaceuticals) Overall global clinical supply planning, forecasting and execution, including transformation projects - Clinical Supply Chain Business Process Improvements, ERP sourcing/implementation planning for SAP ERP. Guided multiple clinical program teams, led CMO network global supply chain management (Asia, EU, US. ROW). Defined and Implemented global forecasting and supply management meeting requirements with internal client team and suppliers: Developed/Implemented global CMC production scheduling for the client’s organization, utilized by executive leadership and BOD meetings by COO.

In addition to leveraging experience and expertise as a GLG consulting member, successful experience in supporting litigation with successful case outcomes

Wellesley Ma

Developed CMC supply chain project management (supporting global DS/DP with global CDMO’s (Siegfried AG/Patheon), implemented Smartsheet Project Management software within the client’s CMC organization to improve operational collaboration. Earned Smartsheet user certification as part of this engagement.(Keryx Biopharmaceuticals)Provided external supply chain optimization (including dashboards) for a client’s supply network initiatives for two global commercial programs and collaborated on key areas of CMO management continuous improvement.(Ironwood Pharmaceuticals) Project Manager leading a Lean Supply Chain Operational Excellence project for a top 10 global pharmaceutical organization. Earned Lean Six-Sigma Green Belt certification as part of the successful completion of this project. (Sanofi/Genzyme)Led improvement in commercial packaging, labeling, product serialization CMO execution for successful EU commercial product launch. (Akebia Therapeutics)

Charlestown, Ma

Focused on drug development to address F508-del genetic mutations for CF, lead CMC Program Management for all FDL activities (DS, DP, Packaged/Labelled product), for FDL’s clinical portfolio of small molecule compounds, developing and managing CMC timelines for program/project tracking including transition to tableted DP as part of FDL’s Integrated Development Plan (IDP).Managed activities of multiple vendors engaged in drug development, manufacturing, analysis, logistics and delivery of all CMC products worldwide. Participated in CMC vendor sourcing, contract negotiations, reviews and change orders including variance review of budgetary items. Proactively managed project execution including identifying potential risk areas and implementation of mitigation and/or contingency plans.

Cambridge, Ma

Reporting to the VP, Biopharmaceutical Manufacturing and Production (BDP): Provided strategic and tactical procurement leadership utilizing a global network of logistics partners, contract manufacturers and contract testing labs in support of continued development and GMP compliance for our vaccine programs for product at all manufacturing stages utilizing a network of global multiple suppliers. Implemented demand forecasting with Clinical Operations team, led Materials Management implementation of Oracle NetSuite ERP.Implemented global logistics management to meet cGMP standards supporting clinical programs.Lead all clinical packaging and labeling management for our clinical stage vaccine portfolio, provide input regarding key study documents such as protocols and pharmacy manuals.

Franklin, Ma

Collaborated with President to implement processes and systems to improve Supply Chain performance. Project manager for outsourced production operations (NPI) with external partner supporting new product launches including a customer specific product line for Genentech in collaboration with Foam Fabricators.Managed national supply and transportation logistics warehouse network supporting national McKesson flu vaccine, responsible for 3PL distribution: negotiation, contracting, forecasting, planning, inventory management and execution to ensure uninterrupted Influenza Vaccine supply nationwide per contract.

Led Global Supply Management (including CMO partner management and packaging and labelling), with specific responsibility for Clinical/Commercial Drug Product Manufacturing Operations for Enobia for the now approved orphan drug product Strensiq®. Led clinical forecasting and supply management process to improve forecast accuracy and developed effective production planning for the program for API and Drug Product to meet clinical supply requirements. Developed and Implemented Clinical Site Supply System to minimize clinical supply risks for the program.

A biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics. In support of three clinical development programs including a pivotal Phase 3 (9 counties, NA, EU, SA, APAC ), accountable to CEO/Executive team for Global Supply Planning and Execution. led development and implementation of end to end supply modeling (using clinical protocol review to develop meaningful forecasting), implementation of inventory control /production planning system (ERP) utilizing a global virtual CMO model and IRT.Managed global activities with global CMO’s/CRO’s (Lonza, Patheon, Quintiles, Almac Clinical Services). Lead Supply Chain Logistics organization for all clinical and commercial supply planning and operation from API/Drug Substance through Drug Product and Fill/Finish & Global Distribution for multiple programs. Sole responsibility for CSO management, including packaging, labeling, and including global distribution of program trial supply, management of effective interaction of CRO and CSO to support supply management and maintain blinding while meeting GMP, GCP compliance standards. Organizational responsibility for performance management of Clinical Supply Chain, manufacturing, distribution and logistics to meet corporate and departmental goals. Define production schedule for CMO’s and manage internal/external resources. Direct execution of manufacture and release timing to meet supply requirements. Participate in selection and approval of CMO’s, technology transfer, perform site surveys and operational audits as needed to support all Altus Pharmaceuticals programs.Business owner of Supply Chain Management System project to improve inventory visibility and management of CMO’s (including development of Supply Chain Metrics and to improve Altus production planning and oversight. Represent Technical Operations group for Commercial Launch Planning (QC, PD, PE, SCL, CM).

Multi-product Life Sciences firm engaged in discovery, development and commercialization of a portfolio of therapies. Led ERP project initially selecting Ross Systems for future transition to SAP. Led GMP Purchasing and Global Supply Planning & Scheduling function for multiple sites (with several direct reports) to meet Clinical and Commercial market demand requirements supporting a portfolio of products (Replagal®, Elaprase®, and Vpriv®), all manufactured in-house, with multiple warehouse locations and extended supply chain network. Introduced organization to Supply Management at all levels and drove adoption supporting material planning and procurement for multiple programs: Material Requirements Planning (MRP) system development and implementation, Process Maps for Departmental Functions (Planning, Purchasing, MM/Inv Control), Bill of Material (BOM) implementation, Managed Operational (CMC) Purchasing and Planning personnel to meet clinical and commercial market demand requirements. Achieved 45% inventory reduction via design and implementation of an optimized material planning process. This implementation enabled supply availability while minimizing inventory investment by implementing ASCM/APICS standards like Bill of Materials (BOM), and Material Requirements Planning (MRP), which were mot previously utilized within Manufacturing Ops. .Led SCM conformance to cGMP standards. Authored Sarbanes-Oxley (SOX) narratives; MRP modeling, execution and reporting, ERP implementation project leadership, improved Technology Transfer to support execution to schedule and assure product supply and cost management. Managed Supply Planning with CMO and transition to insourcing for a portfolio of products. Mentored and managed GMP purchasing activities and material planning group as part of this position. Led negotiation of purchasing contracts including supply agreements for critical materials including supplier audits and performance management.

Waltham, Massachusetts, United States

Industry leader in developing supply chain collaboration systems for the CPG market and e-commerce trading exchanges. Products: Supply, Demand, and CPFR (Collaborative Planning, Forecasting, and Replenishment). Analyzed inventory management and purchasing processes of large CPG/Retail trading partners (P&G, Walgreens, Target, Schering Plough, Kelloggs, Sainsbury, etc.) and managed collaborations.Managed, designed and developed methodology for product enhancements to support Management Reporting as a module of the Syncra Collaborative Product Platform.

Milwaukee, Wisconsin, United States

An industry leader in the development of fully integrated supply chain management solutions. Focused on high-volume distribution clients (WW Grainger, GE Supply, Keystone Automotive). Senior Business Consultant - Solutions Delivery (Purchasing/Inventory Replenishment)Collaborated with lead architects on performance issues, future development and product positioning of Purchasing/Inventory Replenishment and Financial modules.Led development and implementation of supply chain strategy and systems for several clients, with specific focus on Purchasing/Inventory Replenishment implementation and client adoption.

Westwood, Massachusetts, United States

A Global Life Sciences Manufacturer of diagnostics instrumentation and biologic consumables.. Led Inventory Management/Operational Finance functionManaged site inventory valued at 30M, 90% of Global Inventory total to support global revenues of 1BImplemented SAP MM as a part of this role