Mike Gilbert Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

Led all aspects of commercial drug substance, drug product, and finished goods supply planning, capacity planning, labeling/packaging development and operations, production scheduling and execution, and risk management for Sage’s commercial products while driving inter-organizational New Product Launch team to deliver multiple presentations of ZURZUVAE® on-time and in-full o Designed, developed, and implemented new Oral Solid Dose (OSD) labeling and packaging for bottle and blister Finished Goods at multiple Contract Manufacturing Organizations (CMOs) o Established new manufacturing processes and controls through direct oversight of successful CMO launch operations for ZURZUVAE®o Initiated and led the Sales and Operations Planning (SnOP) process across line functions and organizations with commercialization partnero Calculated and communicated inventory targets and net production requirements to key business partners and CMOs to ensure continuous commercial supplyo Authored Finished Goods sections for New Drug Application (NDA) and Annual Product Reviews (APRs) for all commercial programso Ensured DSCSA and Regulatory compliance as Business Process Owner (BPO) for several critical systems including TraceLink and Oracle Cloud ERP Inventory Management System (IMS)o Actively communicated, collaborated with, and contributed to adjacent functional areas including Commercial Operations, Regulatory Affairs, Quality Assurance, CMC, Finance, and external partners to drive teams to achieve the best business results for the company

Us

Biopharmaceutical Supply Chain

Cambridge, Ma, Us

Provide strategic direction, and oversight of all aspects of a clinical/commercial supply chain. Manage the supply chain for a portfolio of development programs across all phases of development through collaboration with various functions including external CRO’s and CDMO’s. Establish and build the supply chain function and supply chain management of multiple clinical programs working closely with Clinical Operations, Technical Operations, Quality, Regulatory Affairs. Ensure that the organization is well-positioned to meet development and clinical material/production needs and execute flawless launches of new commercial products.• Define, execute and lead strategic initiatives for supply chain forecasting and management, including cost reduction and risk reduction opportunities, inventory optimization and other activities related to warehousing of materials and materials management improvements (including but not limited to inventory management systems development). •• Lead end to end supply chain business processes which include Demand Planning and Forecasting, Direct Material Procurement, Expediting, Supply Planning, Master Scheduling and Inventory Management.• Develop and implement a qualification/validated software solution technology for forecasting and planning of Clinical/Commercial Supply Chain pipeline• Partner with Clinical Operations and Commercial to identify demand assumptions, such as enrollment rate, number of sites, number of countries, sales forecasts, launch planning to develop supply requirements plans. • Develop long-term strategies to establish and maintain a robust commercial supply chain, enact appropriate risk mitigation procedures, and monitor and identify future market trends

Cambridge, Ma, Us

Orchestrate the operational aspects of new product launches and global expansions into new geographies. Coordinate Commercial Operations, Portfolio Strategy, Global Supply Chain, Regulatory Affairs, Medical Affairs, and CMC teams to develop product launch strategies and tactical plans.o Partner with Global Commercial Operations to develop the country specific entry strategy for new product introductions and drive visibility within the Supply Chain, Manufacturing, and CMC organizations o Ensure that Global Commercial Demand is aligned with manufacturing capabilities and Clinical Development Plans while alleviating resource constraints across the entire product portfolioo Participate in the development of target product profiles and ensure alignment across the Tech Ops organizationo Ensure new product introduction plans incorporate multiple launch scenarios and account for any potential changes in strategyo Create KPIs for the business, new market entry, and product launches

Marlborough, Ma, Us

Cambridge, Ma, Us

Accountable for US Commercial and Global Clinical Assembly, Label & Pack (AL&P) manufacturing operations. Provided direction for team of strategic Contract Manufacturing Organization (CMO) managers. Responsible for implementation of Corporate brand protection and product security initiatives. Managed total OPEX and CAPEX budget of ~$30MM in annual spend. Represented manufacturing operations on Asset boards, Program teams, and Sourcing councils. o Lead establishment of new manufacturing processes through direct oversight of successful CMO launch operations for seven (7) product families: Tecfidera®, Alprolix®, Eloctate®, Plegridy®, Zinbryta®, Spinraza™, and the Global Humanitarian Aid Donation programo Implemented Serialization capabilities and processes across multiple production lines at multiple CMOs ahead of Drug Supply Chain Security Act (DSCSA) ahead of Nov’17 deadlineo Championed Strategic Relationship Management (SRM) approach to vendor management governance with initiation of standardized processes for performance measures, reporting, communications, and conflict resolutionso Orchestrated cross-functional steering committees consisting of both internal and external representatives to ensure accomplishment of corporate goals and initiativeso Coached team members and develop individual talent leading to the promotion of two (2) team members in 2016o Negotiated vendor pricing to achieve >$1MM of annual cost reduction

Cambridge, Ma, Us

Cambridge, Ma, Us

Cambridge, Ma, Us

Arlington, Virginia, Us

San Francisco, California, Us

Bonn, De

Victor, New York, Us

Cambridge, Ma, Us

Cambridge, Ma, Us