Kit Manufacturing Operations Lead

Overview 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. Job Location: US‑NC‑Morrisville. This onsite role is based in Research Triangle Park, North Carolina. 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. Oversee and execute project deliverables within the approved timeline. Generate and report function metrics related to process controls (production metrics). Track annual cost savings and cost avoidance. Collect continuous improvement ideas and review them monthly with operational leadership. Drive evolution of internal systems to identify improvement opportunities, including 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. Qualifications Bachelor’s degree in life sciences, engineering, or related field. Lean/Six‑Sigma yellow belt or higher preferred. 3–5+ years of experience supporting manufacturing or commercial laboratory operations, production, inventory management, fulfillment, or supply chain operations within a life sciences, diagnostics, or 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. Experience with project management tools is a plus. Strong analytical and problem‑solving skills with the ability to identify operational issues and implement practical solutions. Proven ability to work independently and within a team in a fast‑paced, evolving environment with changing priorities. About Us Metabolon, Inc., is the global leader in revealing biological insights on disease state and physiological reactions in the present time through metabolomics. Leveraging one of the world’s most diverse and rich patient data sets, Metabolon is equipped to deliver biologically relevant evidence to address some of the most difficult and pressing questions in the life sciences. Every day, our work is helping to accelerate research and product development success in the biopharma, population health, consumer products, agriculture, wellness and academic research sectors. Metabolon was founded in 2000 and is based in Research Triangle Park, North Carolina, with an international headquarters in Germany. For more information, please visit Metabolon is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State, or local laws. All employment decisions are based on valid job‑related requirements. #J-18808-Ljbffr NCBiotech