Responsible for the project management and planning of manufacturing and supply chain activities for products used in phase I-III clinical trials and drug development manufacturing. This is accomplished by interacting with project representatives from multiple cross-functional groups including API development teams, formulation, analytical, QA and other R&D manufacturing sites worldwide.

•  Develop supply chain and operational strategies to assure the pilot plant and project teams meet API and/or drug product delivery requirements.  Identify any conflicts and resolve issues that may impact the schedule, including issues related to quality, safety, material or equipment availability.
• Responsible for identifying project specific requirements, such as special commodity needs, packaging and lot distribution requirements and assures all factors are ready for manufacturing start.
• Responsible for raw material and commodity sourcing of pilot plant programs.
• Manage external manufacturing programs for resupply campaigns, as needed. Coordinate with third party manufacturers to support manufacturing campaigns and manage process orders and shipping.
• Collaborates with the materials manager, program manager, and/or team lead to set expectations for procurement needs.  Identifies significant changes in forecast volumes or deliveries that may require a change in purchasing strategy or adjustment in manufacturing timelines and drives any gaps to resolution.
• Collaborates with project teams and commercial operations during product tech transfer to establish expectations and set strategies for material transfers and deliveries.
• Responsible for the SAP production planning for his/her assigned projects. This includes BOM maintenance, master recipes and issuing process orders or equivalent to the warehouse for staging and to manufacturing for production.
• Tracks and communicates project timelines, activities and logistics.  Generates metrics for area KPI reviews.
• Lead process improvement initiatives to streamline supply chain and operational activities for the pilot plant.
• Participates in cross functional initiatives, as needed.