Program Manager, MES

Description

The role leads cross-functional teams that plan and run assembly, labeling and packaging for drug delivery devices and combination products.

You will coordinate all manufacturing and technical work needed to move assigned products into production and onto the market, working with R&D, S&T, Quality, Supply Chain and Regulatory.

After launch, you will oversee capacity planning, supply assurance and cost reduction across the network.

Responsibilities

• Build and direct matrixed teams of scientists and engineers covering process development, manufacturing, quality assurance and quality control across several sites
• Deliver site transfers, new indications, new presentations and lifecycle projects for products already on the market, on schedule and within budget
• Find technical and project plan problems early, troubleshoot them and drive them to resolution with every affected function
• Run several projects at once with limited oversight
• Map out project drivers, requirements and options, and build contingency and risk mitigation plans ahead of need
• Balance competing timelines and make hard calls on project priorities
• Report project status clearly to senior Operations leaders and other stakeholders
• Set program and project plans, timelines and budgets that support business and organizational goals, and make sure they are met
• Set budget requirements and report monthly actuals, LBE and Plan/LRP schedules against the financial calendar

Requirements

• Bachelor's degree in engineering, science or a closely related field, or equivalent technical experience with proven competence
• 10+ years of combined experience in process development, project management, engineering or process support, and manufacturing
• Strong working knowledge of GMP manufacturing, supply chain, validation, engineering, CMC technical development and pharmaceutical regulations
• Strong organizational and planning skills, with excellent spoken and written communication
• Proven project management skills and a record of delivering projects
• Ability to help resolve complex scientific, technical, analytical and business issues across functions
• Plant experience is required
• PMP certification is a plus
• Fluency in more than one language is a plus

Conditions

Pay range applies only to roles in locations with pay disclosure laws. The range is the base pay the company expects to offer for this grade in good faith, and actual pay depends on factors such as location and may fall above or below it. The range may change.

The role is eligible for long-term incentive programs.

Pay extras, bonuses and other incentives are at the company's sole discretion, are not wages until earned and vested, and may change in line with applicable law.

The company is an equal opportunity employer. Open to US and Puerto Rico residents only.

Benefits

• Paid time off covering vacation, holidays and sick leave
• Medical, dental and vision insurance
• 401(k) for eligible employees