Senior Project Manager

Meridian Bioscience, Inc. • Remote,

11d • Hybrid

About The Position

The Senior Project Manager leads complex, cross-functional new product development projects for in vitro diagnostic (IVD) assays and diagnostic instrument systems in an FDA-regulated medical device environment. This role is accountable for project planning and execution from concept through launch, with emphasis on design control compliance, schedule, risk, resources, budget, dependencies, and clear decision-making. The Senior applies deep project management experience to anticipate and resolve complex issues, align cross-functional stakeholders, and drive timely decisions and escalations with limited oversight. The Senior Project Manager partners with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing, and external development partners to achieve business and product objectives. The position may be based locally in Cincinnati or performed remotely, with travel as required to support project teams and key milestones.

Requirements

• Bachelor’s degree in science, engineering or business administration or related field required; advanced degree preferred.
• At least 7 years of project management experience leading cross-functional product development projects, including significant experience managing complex, multi-functional projects from concept through launch.
• Direct experience managing FDA-regulated vitro diagnostic (IVD) product development projects, with demonstrated responsibility for schedule, risk, resources, budget, and cross functional execution.
• Proven track record of successfully leading IVD products through FDA clearance or approval and commercial launch in the U.S. market.
• Strong working knowledge of medical device design control requirements and product development processes, including design planning, design reviews, risk management, verification and validation, transfer, regulatory submission, and launch readiness.
• Demonstrated experience with IVD products, including assay and/or diagnostic instrument development.
• Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations.
• Demonstrated advanced Project Management skills with proven record of practical project management experience preferably in the diagnostic field
• Demonstrate successful leadership of product development projects with significant technical, regulatory, operational, and/or cross-functional complexity.
• Must have strong capability to perform critical path analysis, dependency management, risk management, and scenario planning.
• Excellent problem-solving and decision-support skills.
• Must be a self-starter, detail-oriented and able to prioritize competing demands, balance workloads and timelines and ability to work on multiple projects simultaneously
• Must be able to work independently with limited oversight while influencing and collaborating with peers, functional leaders, senior stakeholders, and external partners in a cross functional setting
• Must be well organized and have the ability to meet strict deadlines and perform under pressure in a fast-paced work environment
• Excellent interpersonal, organizational, written and oral communication skills
• Basic understanding of IVD product development, including assay and/or instrument development, engineering, verification and validation, regulatory, quality, clinical, manufacturing, transfer, and launch activities.

Nice To Haves

• Preferred: Project management qualification (PMP) or equivalent.

Responsibilities

• Partner with R&D, Operations, Regulatory Affairs, Quality, Clinical Affairs, Finance, and Marketing and others to define project scope, goals, deliverables, success criteria, and governance for complex product development projects
• Develops and maintains accurate, achievable integrated project plans and timeline, including critical path, dependencies, resource needs, and key decision points; consistently communicates the plans and changes with team members and the leadership team
• Drives team ownership and commitment to project plans; proactively identifies risks, issues, and tradeoffs and recommends changes needed to meet project objectives
• Tracks, analyzes, and communicates project performance, including schedule, milestones, risks, resources, and budget, and provides clear status, forecasts, and escalations to leadership
• Ensures on-time completion project deliverables in accordance with project commitments, design control requirements, and applicable company procedures
• Leads and facilitates effective cross-functional project team, decision making, issue resolution, and alignment across functions and external partners
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Senior