Program Manager, MES

Description

The role leads matrixed teams that plan and run programs for assembling, labeling and packaging drug delivery devices and combination products.

You will coordinate all manufacturing and technical work needed to move assigned products into production and launch them, working across R&D, science and technology, quality, supply chain and regulatory.

After launch, you manage the product's capacity plan, supply assurance and cost reduction work across the network.

The company sits in the pharmaceutical space and focuses on immunology, oncology and neuroscience, plus aesthetics products.

Responsibilities

• Build and lead cross-functional teams of scientists and engineers covering process development, manufacturing, quality assurance and quality control across multiple sites
• Deliver site transfers, new indications, new presentations and lifecycle projects for marketed products on schedule and within budget
• Find technical and project plan issues early, work with every relevant function to resolve them, and drive decisions
• Run several projects at once with limited supervision
• Understand project drivers, requirements, scenarios and options, and build contingency and risk mitigation plans
• Balance competing timelines and make hard calls on project priorities
• Report project status clearly to senior Operations leadership and stakeholders
• Set program and project plans, including timelines and expenses, that meet business and organizational goals, and make sure they are met
• Define budget needs and report monthly actuals, LBE and Plan/LRP schedules in line with 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 preferred
• Proficiency in more than one language is preferred

Conditions

Pay range applies only where state or local law requires pay disclosure; the company expects to pay within the posted range, with actual pay depending on factors such as location, and the range may change

Any bonus, commission, incentive or other compensation is at the company's sole discretion until paid, and may change under applicable law

The role is eligible for long-term incentive programs

US and Puerto Rico only; the company is an equal opportunity employer

Benefits

• Comprehensive benefits including paid time off (vacation, holidays and sick leave), medical, dental and vision insurance, and a 401(k) for eligible employees