Program Manager, MES (Hybrid)

Role Summary

The MES Program Manager is an experienced leader responsible for managing large global projects across disciplines and multiple manufacturing locations. This role provides leadership and coordinated project management for all manufacturing and/or technical activities needed to ensure successful tech transfer and commercialization of assigned products by integrating R&D, S&T, Quality, Supply Chain, and Regulatory. After product launch, the role manages the capacity strategy for the product, assurance of supply programs and cost reduction initiatives across the network. They organize and lead high-performing cross-functional teams in the planning and execution of device and combination product industrialization programs.

Responsibilities

• Assemble and lead matrixed cross-functional teams comprised of scientists and engineers responsible for all operational aspects of process development, manufacturing, quality assurance and quality control spanning multiple sites
• Implement site transfers, new indications, new presentations and lifecycle projects for on-market programs on time and within budget
• Proactively identify and drive technical and project plan related issues to closure by working with all relevant functional lines and effectively troubleshooting and driving decisions
• Manage multiple projects concurrently, operating with minimal supervision
• Understand project drivers, requirements, scenarios and options. Proactively drive development of contingency and/or risk mitigation plans
• Manage competing timelines and make difficult decisions regarding priorities among projects
• Effectively communicate and present project status to Operations senior management and stakeholders
• Accountable for setting program and project plans, including timelines and expenses, that meet business and organizational objectives and ensuring those plans are achieved
• Define budget requirements and report monthly actuals, LBE, and Plan/LRP schedules per financial schedule

Qualifications

• Bachelor‚Äôs Degree in Engineering, science, or closely related discipline, or equivalent technical experience plus demonstrated competence
• 10+ years of combined experience in positions related to process development, project management, engineering/process support and manufacturing
• Strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations
• Demonstrated organizational and planning skills, excellent verbal and written communication skills
• Demonstrated strong project management skills with successful delivery of projects
• Ability to facilitate the resolution of complex scientific, technical, analytical and business issues across functional lines
• Plant experience required
• PMP certification a plus
• Proficiency in multiple languages a plus