Kit Manufacturing Operations Lead

Metabolon • Morrisville, NC

10d • Onsite

About The Position

Metabolon is seeking a Manufacturing Operations Lead who will report to the Vice President of Operations and serve as the primary operational resource supporting product launch and scale-up of Metabolon's LC-MS kit manufacturing. This individual contributor role will focus on hands-on manufacturing and fulfillment and will participate in the development and validation of manufacturing processes to support commercial launch, regulatory compliance, and general evolution of the company. This role is an onsite role based in Research Triangle Park, North Carolina.

Requirements

• Bachelor’s degree in life sciences, engineering, or related field
• 3-5+ years of experience supporting manufacturing or commercial laboratory operations, production, inventory management, fulfillment, or supply chain operations within life sciences, diagnostics, or related regulated environment.
• Experience in a commercial analytical laboratory preferred.
• Experience creating and maintaining technical documentation, work instructions, specifications, validation documents, or controlled records.
• Demonstrated ability to lead initiatives and coordinate work across teams, leveraging collaboration, influence, strategic planning, and clear communication to align stakeholders and achieve shared objectives with or without direct supervisory responsibility.
• Strong communication and interpersonal skills with the ability to translate operational needs into actionable plans, coordinate across multiple functions, and provide clear updates on project status, risks, and performance metrics.
• Proven ability to balance strategic thinking with hands-on execution.
• Strong project management and organization skills with a high level of attention to detail.
• Strong analytical and problem-solving skills with the ability to identify operational issues and implement practical solutions.
• Proven ability to work both independently and within a team in a fast-paced, evolving environment with changing priorities.

Nice To Haves

• Lean/Six-Sigma yellow belt or higher preferred.
• Experience with project management tools a plus.

Responsibilities

• Own and participate in execution day-to-day LC-MS kit manufacturing, assembly, inventory management, procurement, and shipping activities.
• Develop project documentation with manufacturing subject matter experts to include user requirement specification, validation documentation and related summary reports. Analytical method development and validation is out of scope of this role.
• Oversee and execute project deliverables within the approved timeline.
• Generation and reporting of function metrics related to process controls (production metrics)
• Tracking of annual cost savings/cost avoidance
• Continuous improvement idea collection and monthly review with operational leadership.
• Evolution of internal systems to drive identification of improvement opportunities. This includes the Operational Dashboard, equipment failure mode analysis and Quarterly Business Review performance metrics.
• Lead LEAN/Six-Sigma activities such as gemba walks, WorkOut, Lean 7 Waste reviews and others.

What This Job Offers

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