Program Manager, MES
About The Position
The Program Manager, MES organizes and leads high-performing cross-functional teams in planning and executing programs involving assembly, labeling, and packaging of drug delivery devices and combination products. The role provides leadership and coordinated project management for manufacturing and technical activities needed to support successful technology transfer and commercialization, integrating efforts across R&D, S&T, Quality, Supply Chain, and Regulatory. After product launch, the position manages product capacity strategy, assurance-of-supply programs, and cost-reduction initiatives across the network.
Requirements
- Bachelor’s degree in Engineering, science, or a closely related discipline, or equivalent technical experience plus demonstrated competence.
- 10+ years of combined experience in roles related to process development, project management, engineering/process support, and manufacturing.
- Strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development, and pharmaceutical regulations.
- Demonstrated organizational and planning skills.
- Excellent verbal and written communication skills.
- Demonstrated strong project management skills with successful project delivery.
- Ability to facilitate resolution of complex scientific, technical, analytical, and business issues across functional lines.
- Plant experience.
Nice To Haves
- PMP certification.
- Proficiency in multiple languages.
Responsibilities
- Assemble and lead matrixed cross-functional teams of scientists and engineers responsible for operational aspects of process development, manufacturing, quality assurance, and quality control across multiple sites.
- Implement site transfers, new indications, new presentations, and lifecycle projects for marketed programs on time and within budget.
- Identify and drive technical and project-plan issues to resolution by coordinating with relevant functional groups, troubleshooting, and driving decisions.
- Manage multiple projects concurrently with minimal supervision.
- Understand project drivers, requirements, scenarios, and options; proactively develop contingency and risk-mitigation plans.
- Manage competing timelines and make decisions about priorities among projects.
- Communicate and present project status to Operations senior management and stakeholders.
- Set program and project plans, including timelines and expenses, aligned with business and organizational objectives, and ensure the plans are achieved.
- Define budget requirements and report monthly actuals, LBE, and Plan/LRP schedules according to the financial schedule.
- After product launch, manage product capacity strategy, assurance-of-supply programs, and cost-reduction initiatives across the network.
Benefits
- Paid time off (vacation, holidays, and sick leave).
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Participation in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
