Senior IVD Lab Operations & Manufacturing Lead

Insight Molecular Diagnostics Inc; Glenview (TN); On-site; USD 105,000 - 110,000; Full time

Job summary

Insight Molecular Diagnostics in Nashville, TN seeks a Laboratory Operations & Manufacturing Manager to oversee both the laboratory and formulation/quality control testing of IVD products, ensuring compliance with ISO 13485, FDA QSR (21 CFR 820), GMP and CLIA/CAP. This is a permanent, full-time role bridging Product Development, Manufacturing and Quality Assurance.

You will lead scheduling, equipment oversight, documentation, audits readiness, and a culture of quality while coordinating teams

Qualifications

• Bachelor’s degree in biology, molecular biology, biochemistry, clinical laboratory science, or related field
• 5+ years of laboratory experience in molecular diagnostics, biotechnology, clinical laboratory, medical device manufacturing, or regulated life sciences environment
• 3+ years of direct experience in the IVD medical device or molecular diagnostic industry, with a demonstrated history of executing batch records, validation protocols, and QC testing.
• Familiarity with regulated quality systems (CLIA, CAP, ISO 13485, Design Control, GMP, and 21 CFR 820). Experience supporting FDA or Notified Body audits is preferred.
• Exceptional written and verbal communication skills; ability to collaborate cross-functionally with senior leadership and scientific staff.

Responsibilities

• Coordinate daily laboratory scheduling and workload prioritization.
• Schedule and conduct manufacturing and formulation activities, including reagent preparation, assembly, sampling, labeling, and in-process quality checks following approved batch records and SOPs.
• Manage operational readiness for active studies, ensuring continuity across projects, personnel, reagent/consumable inventory, equipment status, and workspace coordination.
• Coordinate with Leadership and Project Management to monitor execution of active studies to ensure continuity across projects and personnel.
• Establish, maintain, and scale laboratory organization, cleanliness, and operational standards to support evolving assay development needs.
• Improve communication, handoff processes, and operational training across laboratory and production personnel.
• Oversee laboratory personnel adherence to laboratory best-practices and ensure that documentation, protocols and reports are written comprehensively and consistent with IVD industry standards.

Skills

Prioritization

Quality systems

Communication skills

Education

Bachelor’s degree in biology or related field

Job description

Insight Molecular Diagnostics in Nashville, TN seeks a Laboratory Operations & Manufacturing Manager to oversee both the laboratory and formulation/quality control testing of IVD products, ensuring compliance with ISO 13485, FDA QSR (21 CFR 820), GMP and CLIA/CAP. This is a permanent, full-time role bridging Product Development, Manufacturing and Quality Assurance.

You will lead scheduling, equipment oversight, documentation, audits readiness, and a culture of quality while coordinating teams