Laboratory Operations & Manufacturing Manager

IMDx; Nashville, Northern (TN, KY); On-site; USD 105,000 - 110,000; Full time

Job summary

Insight Molecular Diagnostics is seeking a Laboratory Operations & Manufacturing Manager to lead the execution of lab and production activities in Nashville, ensuring ISO 13485 and GMP compliance.

The role oversees scheduling, equipment maintenance, batch records, and process validation, working with R&D, Manufacturing, and QA to deliver reliable diagnostic products.

Qualifications

• Bachelor’s degree in biology or related field.
• 5+ years lab experience in molecular diagnostics or life sciences.
• 3+ years in IVD or molecular diagnostics with batch records and QC testing.
• Familiar with CLIA, CAP, ISO 13485, GMP, 21 CFR 820.

Responsibilities

• Coordinate daily lab scheduling and workload prioritization.
• Oversee manufacturing and formulation activities with SOPs.
• Ensure regulatory compliance with ISO 13485, GMP, and 21 CFR 820.
• Maintain batch records, logs, and validation protocols.
• Lead cross-functional collaboration between labs, manufacturing, and QA.
• Forecast and manage reagent and consumable inventory.
• Prepare for audits and inspections.

Skills

Project management

Cross-functional collaboration

Communication

Prioritization

Quality systems

Education

Bachelor’s degree in biology or related field

Tools

IQ/OQ/PQ

Job description

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Laboratory Operations & Manufacturing Manager

Full Time 30-39 Hour Nashville Lab, Nashville, TN, US

8 days ago Requisition ID: 1072

Salary Range: $105,000.00 To $110,000.00 Annually

Who we are:

Insight Molecular Diagnostics is a precision diagnostics company with a mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey.

Mission of the role:

We are seeking a highly motivated and experienced Manager of Lab Operations & Manufacturing Manager to join our team in a permanent, full-time capacity. This individual will oversee both the technical laboratory ecosystem and the formulation and quality control testing of In Vitro Diagnostic (IVD) medical device products.

This role serves as a critical bridge between Product Development, Manufacturing, and Quality Assurance. The ideal candidate will ensure efficient day-to-day operations, lead process validation and design transfer, and enforce compliant execution of laboratory and manufacturing processes. All activities must strictly align with ISO 13485, FDA QSR (21 CFR 820), GMP principles, and CLIA/CAP design control frameworks.

Laboratory & Production Operations

• 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.

Equipment & Facility Oversight

• Maintain comprehensive oversight of laboratory and manufacturing equipment, including preventive maintenance, calibrations, assets records, and qualification protocols and records (IQ/OQ/PQ).
• Coordinate equipment troubleshooting, vendor service, and operational uptime.
• Track facility-related operational issues including HVAC, humidity, power stability, and environmental controls.

Quality Systems, Documentation & Compliance

• Apply working knowledge of GMP principles, ISO 13485, and 21 CFR 820 requirements to ensure process consistency and compliance
• 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 escape gaps between documented procedures and operational practices.
• Coordinate laboratory operational readiness for audits, inspections, and product development activities.

Team Coordination

• Manage and coordinate staff scheduling, task ownership, and study progression.
• Work collaboratively with scientists and managers to support assay development and validation efforts.
• Facilitate operational meetings and daily maintenance activities.
• Assist with onboarding and operational training of laboratory personnel.

Resource & Inventory Management

• Establish, maintain, and forecast reagent, consumable, and raw material management processes.
• Coordinate laboratory inventory and consumable management to prevent workflow disruptions due to material shortages or equipment downtime.
• Implement and manage the laboratory inventory, supply management program, and forecasting of operational needs.
• Identify operational inefficiencies and implement sustainable laboratory systems.
• Develop scalable operational workflows that support evolving assay development needs.
• Partner with leadership to improve execution consistency and reduce operational risk.
• Monitor laboratory key performance indicators.

What it takes to do this job:

• Education and Experience:
  • 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.
• Skills and Competencies:
  • Proven ability to manage competing priorities across multiple projects in a fast-paced, dynamic environment.
  • 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.

Physical Demands:

• Standing, sitting, walking, bending, reaching, manual manipulation, and lifting 25 pounds.
• Ability to have full-body movement
• All candidates must take a color vision test.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.

Who you are:

• You have a “do what it takes – no job is too small” team player and a positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
• A team player who is curious, adaptable, and willing to learn new techniques or concepts.
• Your organizational skills, attention to detail, and ability to multi-task are excellent.
• A proactive problem-solver who takes ownership of assigned tasks.
• You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.

You will have the opportunity to:

• Meaningfully impact the company’s short-term and long-term success.
• Work collaboratively across all levels within the organization.
• Grow your role as you see fit.
• Learn everything there is to know about cancer diagnostic laboratories.