14 days ago
My client, an innovative pharmaceutical with novel drug delivery system, is looking for a Director Level Candidate to implement a Commercial/Supply Chain solution for their newest product line.
This is an excellent opportunity for the right candidate to build their own department while setting up and implementing a commercial supply chain program that will affect the entire company from a top-down strategy to implentation level.
- Lead the collective supply for all Impel commercial products including
- Commercial forecasting, demand planning and management of commercial drug and device supplies
- Management of the commercial supply, including device component suppliers and assemblers, drug manufacturers, co-packaging suppliers, serialization and 3PL distribution of product.
- Effective function across the continuum of pre-commercial to commercial lifecycle and can create and lead supply chain relationships in consideration of the stage of the program.
- Develops departmental structure, function, and personnel to deliver upon necessary departmental and company Key Performance Indicators.
- Accountable for the S&OP process and the commercial supply chain, directing, driving and facilitating decision making for this process across all Impel programs.
- Assess and communicate risk and opportunity related to the global supply of commercial product.
- Oversee global logistics, product packaging for shipment, and material movement and inventory by CMO.
- Participate on and support product development teams to ensure supplies are provided to achieve key performance indicators.
- Interacts and aligns department function with Impel’s New Product Introduction teams.
- Establish processes to efficiently manage material control at Impel’s suppliers.
- Develops and manages annual departmental budgets for inventory, materials, and logistics within the Commercial Supply function.
- Oversee import/export brokerage relationships and process
- Establish and oversee third party logistics firm(s) for distribution and fulfillment of Impel’s commercial products.
- Establish and oversee implementation and maintenance of serialization compliant with DSCSA at identified CMOs.
- Own and implement the MRP system and process within Impel
- Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained within the approved supply chain.
- Develops and publishes metrics to communicate and manage the effectiveness of the Commercial Supply function leading to increased efficiency, cost reduction and improved customer service.
- Identifies areas for improved efficiency and drives cost reduction for commercial programs through appropriate means.
- Interacts with Finance to ensure alignment of product costing and all financials within the ERP system.
- Assists in developing logistics relationships, plans and procedures.
- Establishes and maintains 3PL relationships, setup, and the ongoing relationship throughout the product lifecycle.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s degree in Business, Finance, Logistics or Engineering.
- Minimum 10 years of related Operations and/or Commercial Supply experience in a fast paced, progressive pharmaceutical, biotech, medical device or other regulated environment. An advanced technical degree or MBA is preferred.
- In-depth, direct experience with the implementation and use of commercially available MRP/ERP systems.
- Deep knowledge of demand planning and experience in participating in, or preferably managing, the S&OP (or SIOP) process.
- Understanding of the end to end Supply Chain and interdependencies across all corporate functions. The ability to collaborate across all levels of the organization and Supply Chain.
- Proven experience in developing and nurturing relationships with critical manufacturing partner in the pre-commercialization and commercialization phase.
- Experience in the successful commercial launch and management of pharmaceuticals, medical devices or combination products.
- Experienced in developing, coaching, guiding and leading a team in the execution and development of strategies to achieve company Key Performance Indicators.
- Experience with best practices related to supply, inventory management and 3PL distribution for commercial products.
- Direct knowledge of import/export regulation as it pertains to FDA regulated products is highly preferred.
- Must be proficient in Microsoft Office and Visio. Proficiency with Business Central, Microsoft Project or Smartsheet is preferred.