Primary Objective of Position
The Director, Commercial Supply Chain will be responsible for overseeing the overall logistics activities and vendor management to support the process flow for the delivery of Commercial goods and services in a domestic and international environment, in a controlled temperature range distribution network.
- Develop and manage lot use strategies with Manufacturing, Regulatory, and Quality; ensuring CMC changes are approved as needed to enable lot use.
- Proven ability to manage external manufacturing/supply organizations. Participate in and lead supplier governance forums.
- Responsible for secondary packaging & labeling activities; leading design and approval activities for generation and implementation of new and revised artwork/labels with Regulatory, Quality, and CMO sites.
- Support launch activities globally
- Develop tools for demand/supply analysis, production planning, volume & capacity studies, and participate in process improvement efforts and other risk mitigation and efficiency efforts.
- Manage/schedule drug substance (DS), drug product (DP), and finished goods (FG) production planning, rolling forecasts, and temperature controlled shipments worldwide in collaboration with Supply Chain Planner and Manufacturing.
- Reduce supply chain risk related to single source suppliers and improve quality of incoming product through continuous supplier qualification process
- Partner with Sr. Director, Supply Chain to develop and formally document supply strategy and processes.
- Establish, update and maintain policies and procedures required to maintain good manufacturing practices (GMP) and good distribution practices (GDP) compliance in the storage, distribution and returns of drug product.
- This position is the team expert in the importation and/or exportation of commercial related materials.
- Assure necessary documentation, permits and/or licenses, are obtained and maintained.
- Establish operational metrics to track, record and improve performance and develop a periodic report that succinctly outlines the supply chain status for management
- Frequent coordination with a cross-functional team of professionals including Commercial Operations, Finance, Manufacturing, Quality, and Regulatory Affairs.
- Prepare documents as needed for regulatory submissions
- Responsible for global serialization implementation, compliance, and ongoing management
- Responsible for supply chain-related ERP activities
- Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and team-orientation
- Other duties as assigned.
Skills & Abilities
- The ideal candidate is well versed in capacity planning, S&OP, materials management and import/export, and must have a strong command of ERP and analytical tools.
- Must have enterprise resource planning (ERP) experience.
- Working knowledge of GMP and good distribution practices (GDP) with focus on commercial supply chain and secondary packaging/labeling processes.
- Proven track record with establishing and maintaining strong internal and external partnerships.
- Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners.
- Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.
- Must have proven experience translating corporate objectives in overall planning, demand forecasting, and supply planning.
- Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
- Must be able to work in a fast-paced environment with minimal direction and have the ability to manage workload with changing priorities.
- Some travel required.
- Ability to remain seated for long periods of time while working on computer or referring to documents.
- Must have manual dexterity to operate computer keyboard and standard office equipment.
- Positions: Standing, walking, sitting, stooping
- Travel may
- A BA/BS degree in supply chain management or related discipline.
- MBA is a plus
- Experience with CMO and/or vendor oversight as well as supplier relationship management (SRM) experience.
- 10+ years in supply chain role and at least 5 years leadership experience in controlled temperature pharmaceutical supply management.