Global Laboratory Director, Plasma Operations

KEDPLASMA LLC; Fort Lee (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. is seeking a Senior Director, Laboratory to provide strategic and operational leadership for high-volume laboratory testing, donor screening, serology, NAT, and outsourced labs.

Reporting to the Global Plasma CEO, this executive will oversee end-to-end operations, drive performance, ensure regulatory compliance, and lead continuous improvement across a multi-site environment. The role shapes laboratory strategy, quality, innovation, and operational excellence, supporting

Qualifications

• Bachelor's degree required; preferred field of study in Science, Medical Technology, Microbiology, or a related discipline.
• Master's degree preferred.
• Minimum of 8 to 10 years of management experience.
• Minimum of 5 years of experience serving as a Laboratory Director.
• Previous multi-laboratory management experience required.
• Experience in plasma and/or blood donor screening laboratory operations strongly preferred.
• Strong knowledge of laboratory regulations, accreditation standards, and quality systems.
• Professional certifications such as MT (ASCP), MLS (ASCP), or SBB (ASCP) preferred.
• Demonstrated experience managing operational budgets and financial performance.
• Ability to lead large, complex laboratory organizations across multiple locations.
• Ability to travel up to 60% of the time, including overnight travel to laboratories, vendor sites, plasma collection centers, and company locations.

Responsibilities

• Provide strategic leadership and operational oversight for laboratory testing and donor screening programs.
• Lead multiple laboratory operations, including internal, backup, and contract laboratory networks.
• Ensure compliance with all applicable regulatory, accreditation, quality, and safety requirements, including FDA, CLIA, ISO, AABB, EU, cGLP, and OSHA standards.
• Drive inspection readiness and oversee responses to audits, inspections, and regulatory reviews.
• Develop and execute laboratory strategies that align with organizational goals and support long-term growth.
• Establish scalable processes and operational frameworks that improve efficiency, service delivery, and performance.
• Monitor laboratory productivity, quality metrics, turnaround times, and operational KPIs.
• Oversee technical operations, testing procedures, quality control programs, and laboratory documentation.
• Partner with internal and external stakeholders to identify opportunities for continuous improvement and operational optimization.
• Lead the development and implementation of new testing protocols and laboratory capabilities.
• Ensure timely investigation, escalation, and resolution of atypical, out-of-specification, and non-conforming results.
• Manage departmental budgets, forecasting, financial reporting, and risk mitigation activities.
• Build, develop, and lead high-performing laboratory leadership teams.
• Oversee workforce planning, staffing, succession planning, employee development, and competency programs.
• Promote a culture of accountability, engagement, safety, quality, and operational excellence.
• Communicate organizational goals and monitor progress toward strategic objectives.
• Support executive leadership through data-driven decision making and operational performance reporting.

Skills

Strategic leadership

Regulatory compliance

Multi-site management

Budget management

Cross-functional leadership

Education

Bachelor's degree in Science/related

Master's degree preferred

Job description

Kedrion Biopharma Inc. is seeking a Senior Director, Laboratory to provide strategic and operational leadership for high-volume laboratory testing, donor screening, serology, NAT, and outsourced labs.

Reporting to the Global Plasma CEO, this executive will oversee end-to-end operations, drive performance, ensure regulatory compliance, and lead continuous improvement across a multi-site environment. The role shapes laboratory strategy, quality, innovation, and operational excellence, supporting