Laboratory Operations Manager

MLM Medical Labs; Memphis (TN); On-site; USD 80,000 - 100,000; Full time

Job summary

MLM Medical Labs GmbH in Memphis, TN is seeking an Operations Manager to lead kit building, logistics, and sample management. The role requires coordinating resources, ensuring projects stay on track, and collaborating with internal and external stakeholders.

You will oversee staffing, SOPs, and compliance with GxP standards, while driving continuous improvement and operational excellence in a fast-paced, on-site environment.

Responsibilities

• Organize kit building operations, including capacity and timeline planning.
• Forecast, order, and manage inventory of consumables.
• Support Study Directors with kit design and implementation for new studies.
• Ensure successful execution of inbound and outbound shipments.
• Manage staffing to support timely shipping and receiving activities.
• Ensure shipment tracking through IT systems.
• Provide troubleshooting support for delayed or non-standard shipments.
• Log study samples promptly for laboratory analysis.
• Maintain 100% sample inventory accuracy.
• Coordinate forwarding of samples to partner laboratories.
• Oversee storage of refrigerators, freezers, and deep-freeze storage.
• Assign personnel across operational workstations as needed.
• Review and provide feedback on study and analysis plans.
• Participate in recruiting, interviewing, onboarding, and training employees.
• Conduct performance evaluations and development discussions.
• Coordinate cross-training to enhance workforce flexibility.
• Create, review, and revise SOPs.
• Join Operations, IT, Laboratory, Kit Building, Sample Receipt, and Management meetings.
• Serve as primary contact during external audits.
• Support departmental restructuring and continuous improvement initiatives.
• Contribute to organizational development and operational efficiency.

Job description

This position is on site M-F in Memphis, TN.

Salary DOE, $80-$100k.

Direct Reports: Employees in Kit Building, Sample Management, and Logistics

Position Summary:

The Operations Manager plays a critical leadership role in the oversight, planning, and execution of

kit building, logistics, and sample management activities. This individual serves as a key problem

solver who can adapt to changing priorities, coordinate resources, and ensure customer projects

remain on track. Success in this role requires strong communication skills, operational excellence,

and the ability to collaborate effectively with internal and external stakeholders.

Key Responsibilities

Kit Building

• Organize kit building operations, including capacity and timeline planning for single-center and
• Assist with forecasting, ordering, and inventory management of consumables.
• Support Study Directors with kit design and implementation for new studies.

Logistics

• Ensure successful execution of all inbound and outbound shipments.
• Manage staffing to support timely shipping and receiving activities.
• Ensure shipment tracking through appropriate IT systems.
• Provide troubleshooting support for delayed or non-standard shipments.

Sample Receipt & Management

• Ensure timely logging of study samples (Safety, PK/PD) for laboratory analysis.
• Maintain 100% sample inventory accuracy.
• Coordinate timely forwarding of samples to partner laboratories.
• Ensure proper documentation and storage of all samples.
• Oversee monitoring and documentation of refrigerators, freezers, and deep‑freeze storage.
• Conduct capacity planning in collaboration with Study Directors.
• Assign personnel across operational workstations as needed.
• Review and provide feedback on study and analysis plans.

Leadership & Operational Excellence

• Participate in recruiting, interviewing, onboarding, and training employees.
• Conduct employee performance evaluations and development discussions.
• Coordinate cross‑training initiatives to enhance workforce flexibility.
• Create, review, and revise SOPs.
• Participate in Operations, IT, Laboratory, Kit Building, Sample Receipt, and Management meetings.
• Serve as the primary contact during external audits.
• Support departmental restructuring and continuous improvement initiatives.
• Contribute to organizational development and operational efficiency.

Quality & Compliance Responsibilities

The Operations Manager is responsible for ensuring all assigned tasks are completed

conscientiously and responsibly. Training and workflow familiarity must be documented and verified

through established training records. The role requires compliance with applicable quality standards

and regulations, including DIN EN ISO 15189, FDA and EMA guidelines, GLP principles, GCP

regulations, and Good Clinical Laboratory Practice (GCLP).

The incumbent must review, understand, and follow all SOPs relevant to assigned responsibilities,

maintain documentation of training, and proactively recommend process improvements that

enhance operational performance and quality.