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.     

Responsibilities:

• 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.  Resolution may require some support from supervision.
• 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.
• 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 the 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.
• Participates in cross functional initiatives, as needed.