Program Manager, MES

AbbVie • Irvine, MA

1d

About The Position

The Program Manager, MES organizes and leads high-performing cross-functional teams responsible for programs involving assembly, labeling, and packaging of drug delivery devices and combination products. The role provides coordinated project management and leadership for manufacturing and technical activities needed to support successful technology transfer and commercialization, integrating efforts across R&D, S&T, Quality, Supply Chain, and Regulatory.

After product launch, the Program Manager manages product capacity strategy, assurance-of-supply programs, and cost-reduction initiatives across the network. The position manages multiple projects and their plans, timelines, budgets, risks, and priorities, and communicates program status to Operations senior management and stakeholders.

Requirements

• Bachelor’s degree in engineering, science, or a closely related discipline, or equivalent technical experience with demonstrated competence.
• 10+ years of combined experience in roles 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 and successful project delivery.
• Ability to facilitate resolution of complex scientific, technical, analytical, and business issues across functional lines.
• Plant experience.

Nice To Haves

• PMP certification.
• Proficiency in multiple languages.

Responsibilities

• Assemble and lead matrixed cross-functional teams of scientists and engineers responsible for operational aspects of process development, manufacturing, quality assurance, and quality control across multiple sites.
• Implement site transfers, new indications, new presentations, and lifecycle projects for marketed programs on time and within budget.
• Identify and drive technical and project-plan issues to resolution, working across relevant functional lines to troubleshoot and drive decisions.
• Manage multiple projects concurrently with minimal supervision.
• Understand project drivers, requirements, scenarios, and options, and proactively develop contingency and risk-mitigation plans.
• Manage competing timelines and make decisions about priorities among projects.
• Communicate and present project status to Operations senior management and stakeholders.
• Set program and project plans, including timelines and expenses, to meet business and organizational objectives, and ensure the plans are achieved.
• Define budget requirements and report monthly actuals, LBE, and Plan/LRP schedules according to the financial schedule.
• Manage product capacity strategy, assurance-of-supply programs, and cost-reduction initiatives across the network after product launch.

Benefits

• Paid time off, including vacation, holidays, and sick time.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) for eligible employees.
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior