Program Manager, MES

Description

You will lead cross-functional teams that plan and deliver work on assembly, labeling and packaging of drug delivery devices and combination products.

You will coordinate all manufacturing and technical activities that move an assigned product into production and to market, linking R&D, S&T, Quality, Supply Chain and Regulatory.

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

Responsibilities

• Form and run 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 on existing market products, on schedule and within budget.
• Spot technical and project plan problems early, work with every affected function, and push each one to a decision and closure.
• Handle several projects at once with little day-to-day oversight.
• Grasp project goals, requirements, scenarios and options, and build contingency and risk mitigation plans ahead of need.
• Weigh competing timelines and choose which project takes priority when they conflict.
• Report project status clearly and present it to Operations senior management and other stakeholders.
• Set program and project plans, timelines and expenses that fit business and organizational goals, then see that they are met.
• Set budget requirements and report actuals, LBE and Plan/LRP schedules each month 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.
• Solid 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 record, with projects delivered successfully.
• Ability to help resolve complex scientific, technical, analytical and business issues across functions.
• Plant experience a must.
• PMP certification a plus.
• Proficiency in more than one language a plus.

Conditions

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

This role is open only to applicants in the US and Puerto Rico.

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

Benefits

• Comprehensive benefits, including paid time off for vacation, holidays and sickness, medical, dental and vision insurance, and a 401(k) plan for eligible employees.
• Eligibility for long-term incentive programs.
• Any bonus, incentive or other pay or benefit is at the company's discretion until it is paid and may change, consistent with applicable law.