IVD Lab Operations & Manufacturing Leader

Energy Jobline ZR; Nashville (TN); On-site; USD 120,000 - 180,000; Full time

Job summary

Insight Molecular Diagnostics seeks a seasoned Manager of Lab Operations & Manufacturing to oversee both laboratory and manufacturing activities for IVD products. The role ensures compliance with ISO 13485, FDA QSR (21 CFR 820), GMP, and CLIA/CAP frameworks while aligning with Product Development and Quality Assurance.

You will lead scheduling, batch records, training, vendor coordination, and continuous improvement to support evolving assay development and study continuity across projects.

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 .
• 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.
• Maintain laboratory notebooks, batch records, maintenance logs, and validation protocols in a complete, traceable manner following quality assurance requirements.
• Identify and access process risks, implement mitigations, and elevate gaps between documented procedures and operational practices.
• Coordinate laboratory operational readiness for audits, inspections, and product development activities.

Skills

Laboratory operations

Regulated quality systems

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor’s degree in biology, molecular biology, biochemistry, clinical laboratory science, or related field

5+ years laboratory experience in molecular diagnostics or regulated life sciences

3+ years IVD/molecular diagnostic industry experience

Tools

IQ/OQ/PQ validation protocols

ISO 13485 familiarity

Job description

Insight Molecular Diagnostics seeks a seasoned Manager of Lab Operations & Manufacturing to oversee both laboratory and manufacturing activities for IVD products. The role ensures compliance with ISO 13485, FDA QSR (21 CFR 820), GMP, and CLIA/CAP frameworks while aligning with Product Development and Quality Assurance.

You will lead scheduling, batch records, training, vendor coordination, and continuous improvement to support evolving assay development and study continuity across projects.