Lead execution of external manufacturing programs across Contract Manufacturing Organizations (CMOs), including planning, coordination, risk management, and issue resolution.
Track and manage CMO key performance indicators (KPIs) and metrics to drive performance.
Represent ExDM on project teams and align external manufacturing strategies with program objectives.
Manage GMP-related activities such as batch record and specification review, change control, release support, investigations, and material coordination.
Serve as the primary liaison with external partners, driving performance in quality, delivery, and cost.
Oversee billing, purchase orders, and financial forecasting for assigned programs, while improving financial workflows and reporting.
Collaborate across Technical Operations, Quality, Global Clinical Supplies, Procurement, and other partner groups to resolve complex technical and operational challenges.
Identify and implement process improvements across internal workflows and vendor interfaces.
Serve as a subject matter expert in selected technical or business areas and contribute to organizational capability building.
Mentor and support junior team members through coaching, knowledge sharing, and project guidance.
Use digital tools, analytics, and AI-enabled platforms to improve efficiency, decision-making, and communication.
Requirements
B.S. with minimum of 5 years relevant industrial experience, or M.S. with 3 years of experience in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline
Relevant experience in clinical manufacturing, supply chain, or external manufacturing management within the pharmaceutical industry
Working knowledge of GMP operations, batch release, investigations, and quality systems
Strong project management, problem-solving, and stakeholder management skills
Ability to work independently and lead effectively in a matrixed environment
Experience working with external partners or CMOs (preferred)
Advanced degree in a relevant discipline (preferred)
Experience leading external manufacturing or development programs (preferred)
Demonstrated success driving process improvements and scalable solutions (preferred)
Ability to influence across cross-functional teams and external partners (preferred)