Program Manager, MES

Description

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

You will lead project management for the manufacturing and technical work needed to move assigned products into production and onto the market, coordinating R&D, S&T, Quality, Supply Chain and Regulatory.

After launch, you will own the capacity plan for the product, supply assurance programs and cost reduction work across the network.

Responsibilities

• Form and lead 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 marketed programs on schedule and within budget.
• Spot technical and project plan problems early and work with every relevant function to resolve them and reach decisions.
• Run several projects at once with little direct supervision.
• Grasp project drivers, requirements, scenarios and options, and build contingency and risk mitigation plans without waiting to be asked.
• Balance competing timelines and make hard calls on project priorities.
• Present project status clearly to senior Operations leaders and stakeholders.
• Set program and project plans, including timelines and expenses, that support business and organizational goals, and make sure they are met.
• Set budget requirements and report monthly actuals, LBE, and Plan/LRP schedules in line with the financial calendar.

Requirements

• A 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.
• Clear organizational and planning skills, with excellent spoken and written communication.
• A proven record of managing projects and delivering them successfully.
• Ability to help resolve complex scientific, technical, analytical and business issues across functions.
• Plant experience is required.
• PMP certification is a plus.
• Proficiency in more than one language is a plus.

Conditions

Pay disclosure applies only to roles in locations covered by state or local pay transparency law. The posted range is the base pay the company expects in good faith to pay for this grade at the time of posting. Actual pay within the range depends on factors including geographic location, and the company may pay above or below it. The range may change.

Bonuses, commissions, incentives, benefits and other compensation are at the company's sole discretion and are not earned until paid. They may be changed as permitted by law.

The company is an equal opportunity employer. This role is open to US and Puerto Rico applicants only.

Benefits

• Paid time off covering vacation, holidays and sick leave, medical, dental and vision insurance, and a 401(k) for eligible employees.
• The role is eligible for long-term incentive programs.