As the Senior Director, Commercial Manufacturing/Operations you will:
- direct and manage the global manufacture and supply of clinical and commercial products to achieve business objectives
- be accountable for the execution and effectiveness of clinical and commercial demand planning and S&OP process
- operate at the highest levels of decision making related to combination product manufacture and supply.
The ideal hands-on candidate is detail oriented, timeline driven, has a positive attitude, is flexible, organized, multi-tasks, can deal with ever changing priorities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead the collective manufacture and supply for all Impel clinical and commercial products including:
- Clinical demand planning and supply for global studies
- Commercial forecasting, demand planning and management of commercial drug and device supplies
- Management of the commercial supply chain, including device component suppliers and assemblers, drug manufacturers, co-packaging suppliers, and serialization and distribution of product
- Develops departmental structure, function, and personnel to deliver upon necessary departmental and company Key Performance Indicators.
- Accountable for developing and executing an S&OP process
- Assess and communicate risk and opportunity related to the global supply of clinical and commercial product
- Oversee global logistics and material movements
- Participate on product development teams to ensure supplies are provided in time to achieve key performance indicators
- Interacts and aligns department function with Impel’s New Product Introduction teams
- Develops and manages annual departmental budgets for inventory, materials, and logistics within the Operations/Supply Chain 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
- Works with Quality Assurance to ensure Supplier Quality requirements are achieved and maintained.
- Develops and publishes metrics to communicate and manage the effectiveness of the Operations function and the global supply chain 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 within the ERP system.
- Travel up to 30% is anticipated.
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Seven years’ experience in medical device, pharmaceutical or biotech company is required
- Bachelor’s degree in Business, Finance, Logistics or Engineering is required. Minimum 10 years of related Operations and Supply Chain experience in a fast paced, progressive biotech, medical device or other regulated environment is required.
- Experience in the successful management of supply for both clinical and commercial supply of pharmaceuticals, medical devices or combination products is required.
- Experience in the successful management of CMO relationships is required.
- Ability to develop, coach and guide a leadership team in the execution, development of strategies leading to the achievement of company Key Performance Indicators is required.
- In-depth, direct experience with the implementation and use of commercially available ERP systems is required. Knowledge of demand planning and the S&OP process is required.
- Must be proficient in Microsoft Office and Visio.
- Proven experience in developing and nurturing relationships with critical manufacturing partner is required.
- The ability to collaborate and partner across all levels of the organization and Supply Chain is required.
- Demonstrated experience with best practices related to Commercial Manufacturing/Operations
EDUCATION, EXPERIENCE AND/OR SKILLS PREFERRED
- Direct knowledge of import/export regulation as it pertains to FDA regulated products is highly preferred
- Combination Product experience is highly preferred
- An advanced technical degree or MBA is preferred
- Proficiency with Microsoft Project or Smartsheet is preferred