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Click here or scroll down to respond to this candidateCandidate's Name , CPIM CSCPStreet Address Canada Goose Drive Mobile: PHONE NUMBER AVAILABLEHackettstown, NJ Street Address EMAIL AVAILABLEPage 1 Candidate's Name
EXECUTIVE SUMMARYDynamic and highly effective Supply Chain and Operations professional with over 20 years of experience in highly regulated environments including Pharmaceuticals, Biotechnology, and Aerospace Engineering. Specialties include Sales and Operations Planning, technology transfers, production scheduling, capacity planning and modeling, team building, and engineered efficiencies. Deep experience in cross-functional leadership, operational excellence, and portfolio management to develop and drive highly successful organizations throughout my career. PROFESSIONAL EXPERIENCEHARROW HEALTH INCORPORATED: Senior Director, Supply Chain (Ledgewood, NJ) Apr 2022-Apr 2024 Head of Supply Chain for a leading ophthalmic healthcare company specializing in medications prescribed to treat patients managing chronic and acute eye conditions. Responsible for managing 25 employees and a multimillion-dollar annual spend. Accountable for developing and implementing the overall supply chain strategy aligned with corporate business objectives. Manage production and material plans while meeting quality standards and regulatory requirements. Oversaw all Supply Chain requirements for both 503A and 503B pharmacies. Oversee end-to-end supply chain operations, including sourcing, procurement, planning, scheduling, logistics, and inventory management. Developed the Supply Chain strategy in line with the overall corporate strategy, defining production and inventory strategies by product line, long-term planning, and optimization opportunities resulting in the reduction of on-hand inventory by 35%. Directed site planning and scheduling analysts in developing the site master plan and created and facilitated site S&OP program leading to an 80% increase in forecast accuracy. Implemented risk mitigation programs including Gemba walks, FMEA, and dual sourcing of critical materials programs to ease potential disruptions and ensure business continuity. Developed strategic sourcing strategy emphasizing long-term relationships with key suppliers while creating a competitive supplier base decreasing raw material spend by 20%. Led cross-functional project teams responsible for implementing multiple automation solutions and digital tools including Oracle ERP validation, MRP, and Barcode Scanner Implementations. Developed and managed overall cost reduction targets resulting in a $1.1 million cost reduction for 2023. Ensured product launches were timely and implemented following budgetary objectives and timelines. Led a robust 5S program implementation in all warehousing, shipping, and receiving areas. Provide leadership, direction, and guidance to the Demand Planning process, providing the business with a 24-month rolling demand plan for volumes, revenue, and margin. Ensure compliance with regulatory requirements and industry standards in sourcing and procurement. Created raw material and finished goods safety stock strategy to support proper procurement for drug substance and drug product manufacturing campaigns. Direct warehouse activities (including inventory control, shipping, receiving, GMP storage, and cycle counting). Developed short and long-range production plans to meet business profit and growth objectives. FERRING PHARMACEUTICALS, (Parsippany, NJ) Apr 2021-Mar 2022 Director, OperationsHead of Operations for a research-driven, specialty biopharmaceutical group. Ferring is a leader in reproductive medicine, maternal health, and specialty areas within gastroenterology and orthopedics. Managed a team of 70 employees. Operations Director for multiple fill-and-finish product lines. Led Operations and Quality Control tech transfer and was a key drug development team member for the companys first cell and gene Therapy product. Responsible for the Operations Excellence program to expand plant capacity for the existing product portfolio by 33%. Created staffing plans for all departments to maximize staffing efficiencies for updated production schedules. Own development of platform and processes for new gene therapy products and associated manufacturing requirements. Accountable for all Production, Fill, Finish, Inspection and Packaging activities. Candidate's Name , CPIM CSCPPage 2 Candidate's Name
MINARIS REGENERATIVE MEDICINE: Director, Operations and Supply Chain (Allendale, NJ) Apr 2016-Apr 2021(FORMERLY HITACHI CHEMICAL ADVANCED THERAPEUTIC SOLUTIONS) Head of Operations and Supply Chain for a multi-site, multinational Contract Development and Manufacturing Organization in the Cell and Gene Therapy arena. Implemented major electronic systems including ERP and MRP and supporting documentation and best practices. Responsible for an annual revenue stream of over $75 million across a deep portfolio of major companies and products in the Regenerative Medicine industry. Responsible for managing 60 employees and an annual spend of $7MM. Directly accountable for a complete overhaul of the Supply Chain department including all processes and related systems. Built Supply Chain structure from the ground up; including staffing models, alignment of commercial forecasts and marketing plans, utilizing financial and product flows, and ensuring electronic systems to meet supply needs. Established an effective CDMO-focused Sales and Operations Planning process increasing forecast accuracy by 88%. Identified and remediated supply chain gaps and immediate needs to integrate products into the manufacturing network (i.e., increased inventory accuracy from 43% to 99.7%, and reduced material costs by 40%). Designed and built a system to analyze and track resource capacity, including personnel, materials, and equipment. Spearheaded development and documentation of comprehensive standard operating procedures (SOPs) for the supply chain department. Built Project Management Office (PMO)- Established and managed a PMO to oversee all supply chain and operations projects, ensuring consistent application of project management methodologies and successful project execution. Managed production schedule for tech transfers and ongoing clinical manufacturing campaigns while accounting for variables like equipment and facility maintenance in an evolving manufacturing environment. Drove startup operations for a new commercial facility through technical and organizational leadership from the Manufacturing and Operations teams to ensure the project stayed on time and within budget. Led a team of Project Managers assigned to oversee client requirements and satisfaction. Established and maintained key performance indicators driving supply chain performance in the areas of on-time delivery, service quality, cost, quality/compliance, supply chain responsiveness, and speed. Reduced transportation costs by 37% by leveraging optimization models, carrier agreements, and freight consolidation strategies. Drove and ensured compliance with all import and export global regulations to ensure regulatory compliance with foreign and domestic government agencies including customs entries and export filings. Led material transformation, supply planning, purchasing, data management, and inventory accuracy while operating in a dynamic, fast-paced environment maintaining GMP, GCP, GxP, and ICH standards. NOVARTIS PHARMACEUTICALS: Supply Chain Manager (Morris Plains, NJ) Jan 2013 to Apr 2016 Responsible for directing critical path planning and scheduling activities, driving and maintaining ongoing production levels for high- profile manufactured products across a network of 48 clean-room manufacturing suites. Managed a staff of over 50 employees, including Planning, Scheduling, and Warehousing departments. Established an effective Sales and Operations Planning process to increase forecast accuracy, support effective new product launches, and manage product life cycle. Optimized efficiencies by establishing inventory levels and schedules with production sites and global supply chain partners. Business lead for long-term SAP MRP implementation project, creating and managing manual MRP system for use before SAP implementation and successfully eliminating stockouts. Developed detailed ERP system requirements, hosted working sessions with prospective solution providers, and co-chaired the Software Selection Working Group. Led the ERP Steering Committee in framing business cases, designing project governance, and executing a successful SAP implementation's blueprinting and realization phases. Key team member responsible for the creation and development of a unique immunotherapy scheduling and monitoring system Developed and integrated communications process between the production facility, apheresis, and infusion centers, reducing overall order-to-fulfillment time by 15%. Reevaluated suppliers regarding response time and cost to improve our internal production scheduling and inventory replenishment practices. Developed and managed a call center responsible for all external scheduling communications. Candidate's Name , CPIM CSCPPage 3 Candidate's Name
DENDREON INCORPORATED: Planning/Scheduling Manager (Morris Plains, NJ) Jun 2009 to Jan 2013 Responsible for scheduling and planning the first commercialized Cell and Gene therapy product. Developed customized tools and strategies to meet growing business needs and the changing regulatory landscape for the nascent Cell and Gene therapy industry. Developed, tested, and implemented Intellivenge, the first scheduling system to support the Cell and Gene therapy industry. Supply Chain FDA inspection subject matter expert. Created and optimized scheduling methodology for an immunotherapy product line. Responsible for the development and maintenance of production schedules for both commercial and clinical products. Developed and applied best practices regarding time horizon, frozen schedules, and sourcing strategies. Strategized plan to meet higher-than-expected demand for commercial production and successfully drove 6-month capacity expansion plan by redesigning production schedulesincreasing available capacity by 60%. Assisted in guiding the product through the FDA approval process. Reduced manufacturing overtime requirements by 88%. Increased on-time disposition rate to 99.3% and on-time shipping rate to 100%. SPX PRECISION COMPONENTS: Supply Chain Manager (Ronkonkoma, NY) Nov 2006 to Apr 2009 Managed the supply chain team and all aspects of the planning, purchasing, inventory control, shipping/receiving, assembly, and production control departments of a fast-paced aerospace supply firm. Designed and implemented production planning including integrated demand forecasts, high-level production scheduling, capacity and allocation, planning, and yield consideration. EDUCATION/CERTIFICATIONSBachelor of Arts, Legal and Political Communications: Queens College of the City University of New York APICS: Certification in Production and Inventory Management (CPIM) APICS: Certified Supply Chain Professional (CSCP) |
