Laboratory Manager

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma‑derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh‑Sensitization.

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.

• 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

• 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,…