Program Manager, MES
About The Position
The Program Manager, MES organizes and leads high-performing cross-functional teams planning and executing programs for 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 ensure successful technology transfer and commercialization, integrating the efforts of R&D, S&T, Quality, Supply Chain, and Regulatory functions. After product launch, the Program Manager manages product capacity strategy, assurance-of-supply programs, and network-wide cost-reduction initiatives. The position oversees concurrent projects with minimal supervision, establishes program plans and budgets, and communicates project status to Operations senior management and stakeholders.
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 positions 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 delivery of projects.
- 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.
- Proactively identify and resolve technical and project-plan issues by working across relevant functions, troubleshooting, and driving decisions.
- Manage multiple projects concurrently with minimal supervision.
- Understand project drivers, requirements, scenarios, and options, and proactively develop contingency or risk-mitigation plans.
- Manage competing timelines and prioritize among projects, including making difficult decisions.
- Communicate and present project status effectively to Operations senior management and stakeholders.
- Set program and project plans, including timelines and expenses, to meet business and organizational objectives, and ensure 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, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
