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Job Type: Full Time
Category: General Management
The Associate Director/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 multiple 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 primary and 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, initially for US launch followed by international launches.• 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 cold chain shipments worldwide in collaboration with Supply Chain Planner.• 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) 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, Engineering, Manufacturing, Regulatory Affairs.Prepare documents as needed for FDA submissions including IND, NDA, BLA, and other regulatory authorities.• 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. RequirementsQualifications:
• 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) implementation experience.• The associate director will have 8+ years GMP commercial biologics supply chain experience with 3+ years’ leadership experience in cold chain supply management. The director level incumbent will have 10+ years and at least 5 years leadership experience in cold chain supply management.• Three plus years’ contract manufacturing operations (CMO), vendor management, as well as supplier relationship management (SRM) experience.• Working knowledge of GMP and good distribution practices (GDP) with focus on commercial supply chain and manufacturing 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.• A BA/BS degree in supply chain management or related discipline.• Some travel required.
ADDITIONAL KNOWLEDGE AND SKILLS DESIRED, BUT NOT REQUIRED:
• Manufacturing and/or external manufacturing experience a plus• Some supervisory experience, APICS certification, Lean Six Sigma training & project management skills are highly desirable.
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