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 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 take on capacity planning for the product, supply assurance programs and cost reduction work across the network.

The company is a global biopharmaceutical company focused on immunology, oncology, neuroscience and aesthetics.

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 products on schedule and within budget.
• Find technical and project problems early, work with every affected function, and drive them to resolution through clear decisions.
• Run several projects at once with little direct supervision.
• Grasp project goals, requirements and options, and build contingency and risk mitigation plans without waiting to be asked.
• Weigh competing timelines and make hard calls on which projects come first.
• Report project status clearly to senior Operations leaders and other 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 against 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.
• Strong organizational and planning skills, with excellent verbal and written communication.
• A proven record of delivering projects through strong project management.
• Ability to 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.
• Applicants must be located in the US or Puerto Rico.

Conditions

Pay range details: the company expects to pay base compensation within the posted range in good faith, based on the job grade. Actual pay depends on factors such as location and may fall above or below the range, which may change over time.

This role is eligible for long-term incentive programs.

Any bonus, commission, incentive or other compensation is earned, vested and determinable only once paid, and remains at the company's sole discretion, consistent with applicable law.

The company is an equal opportunity employer and welcomes applicants with disabilities and veterans.

Benefits

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