Laboratory Manager
Posted Updated
Job Summary
Lead the science behind life-saving therapies as a Laboratory Manager. In this role, you will oversee daily laboratory operations supporting specialty plasma programs, ensuring accurate testing, regulatory compliance, and high-quality outcomes. You will play a critical role in maintaining laboratory performance, advancing testing capabilities, and delivering results that meet strict industry standards while supporting organizational goals and customer requirements.
What you'll do
- Oversee daily laboratory operations, including testing specialty plasma samples, ensuring accuracy, efficiency, and compliance with regulatory standards such as FDA cGMP, CLIA, and OSHA requirements
- Create, update, and enforce Standard Operating Procedures (SOPs) aligned with the Quality Management System (QMS) to ensure consistent execution of laboratory processes
- Coordinate laboratory testing activities including sample processing, test execution, instrument calibration, maintenance, troubleshooting, and quality control/assurance
- Monitor and validate laboratory test results, ensuring accuracy and reliability across all testing activities
- Manage laboratory inventory, ordering supplies, reagents, and consumables required for uninterrupted operations
- Calculate and evaluate quality control metrics, including standard deviations and calibration standards, to ensure proper test performance
- Oversee outsourced testing processes, including coordinating sample logistics and communication with external laboratories
- Maintain accurate data entry, donor records, and testing documentation, ensuring proper tracking and compliance with program requirements
- Manage specialty program inventory and collaborate with Supply Chain, Quality, and operational teams to ensure appropriate stock levels and customer fulfillment
- Configure and prepare customer sample pools to meet volume and potency specifications, and coordinate shipment execution
- Implement and validate new testing methods, instruments, and procedures to meet evolving customer and regulatory requirements
- Schedule and maintain laboratory equipment, including preventative maintenance, calibration, and validation documentation
- Support internal and external audits by providing required documentation and driving corrective actions where needed
- Communicate effectively with vendors, technical support teams, and customer representatives to resolve issues and maintain service standards
- Oversee licensing requirements and support renewal processes to maintain operational compliance
- Lead, develop, and manage laboratory staff, including hiring, training, coaching, performance management, and workload distribution
- Foster a positive, collaborative, and performance-driven work environment that supports employee engagement and retention
Qualifications and need-to-know
- Bachelor’s degree in Life Sciences or a related field required
- ASCP certification or equivalent national certification required
- Licensed Clinical Laboratory Supervisor across relevant specialties preferred
- 5–10 years of experience in a hospital laboratory, plasma, or blood collection environment preferred
- Knowledge of laboratory testing protocols and viral marker testing preferred
- Strong understanding of regulatory requirements including FDA cGMP, CLIA, and OSHA standards
- Demonstrated experience managing laboratory operations, including quality control, equipment maintenance, and testing procedures
- Proven leadership experience with the ability to manage, coach, and develop team members
- Experience with laboratory data management and documentation processes
- Ability to implement new procedures, validate methods, and adapt to evolving operational requirements