Program Manager, MES

About the role

The Program Manager, MES organizes and leads cross-functional teams in the planning and execution of programs covering the assembly, labeling and packaging of drug delivery devices and combination products. The role coordinates project management for manufacturing and technical activities needed for successful tech transfer and commercialization, integrating R&D, S&T, Quality, Supply Chain and Regulatory. After launch, it manages capacity strategy, supply assurance and cost reduction across the network.

Key responsibilities

• Lead matrixed cross-functional teams of scientists and engineers on process development, manufacturing, QA and QC across multiple sites
• Deliver site transfers, new indications, new presentations and lifecycle projects on time and within budget
• Drive technical and project issues to closure and manage multiple concurrent projects with minimal supervision
• Develop contingency and risk mitigation plans and prioritize competing timelines
• Report project status to senior management and set plans, budgets, timelines and expenses
• Report monthly actuals, LBE and Plan/LRP schedules

Required profile

• Bachelor's degree in engineering, science or a closely related field, or equivalent technical experience
• 10+ years in process development, project management, engineering/process support and manufacturing
• Plant experience is a must
• Strong organizational, planning, verbal and written communication skills
• PMP certification and proficiency in multiple languages are a plus

Required skills

• GMP manufacturing, validation, CMC technical development and pharmaceutical regulations
• Supply chain and engineering knowledge
• Project management and risk mitigation

What we offer

• Benefits including paid time off, medical/dental/vision insurance and 401(k)
• Eligibility for long-term incentive programs