Head Of Supply Chain

Lumicell is seeking a Head of Supply Chain for our Newton, MA office. Note that at extensive medical device experience is required, and ideally someone who's managed an end to end supply chain at a prior medical device company for at least a few years.

Key Responsibilities

• Manage supplier relationships and sourcing for key cGMP components used in Lumicell’s drug and devices; manage consigned inventories of select key components to ensure sufficient material is available to support planned production runs
• Manage the S&OP process across the organization, including gaining agreement on production and inventory plans, and tracking actual production to plan and actual sales to plan
• Manage critical RFPs and sourcing across Lumicell, such as key contracted services, capital equipment, CMO partner selection, etc. Work with the Finance team to configure, implement, and operate a requisition and PO generation system to compliantly manage Lumicell’s sourcing processes
• Co-manage, along with PD partners, Lumicell’s CMOs. Take primary responsibility for managing the business relationships with CMOs, chairing semi-annual JSC meetings, managing production planning and associated purchasing, and tracking and helping to resolve on-going production issues
• Manage Lumicell’s commercial and clinical distribution operations, including managing 3PL warehouses storing and shipping Lumicell product, managing Lumicell’s carriers, import/export/brokerage operations, and maintaining compliance with state distribution regulations for commercial cGMP products
• Manage end-to-end planning for clinical and commercial products, (drug, re-usable device, console, and accessories), including production and inventory planning
• Manage Lumicell’s contract DP Label & Pack operations, including (contract) production management and label control for each DP production run

Requirements / Qualifications

• Experience selecting, contracting/negotiating with, and managing drug and medical device Contract Manufacturers (“CMOs”)
• Experience managing high dollar RFPs for cGMP and non-cGMP services across the organization
• Experience managing Planning for Devices and Drug Product in the life sciences industry, including translating forecasts into production plans, determining appropriate inventory levels, running an S&OP process, and implementing and using ERP
• Experience managing sourcing for in the life sciences industry, including selecting and negotiating with suppliers, managing on-going procurement operations, and working with suppliers to resolve day-to-day operational and quality issues
• Experience managing Devices as well as cold-chain Drug Product for a life sciences company
• 3 years’ experience working for a pharmaceutical manufacturer licensed to sell drug throughout the US (Designated Representative)
• Experience managing contract Label & Pack operations for Drug Product
• 3-5 years (or more) experience managing the entire Supply Chain in the life sciences industry, including responsibility for Planning, Sourcing, and Distribution of clinical and commercial product