Senior Director, Laboratory

Kedrion Biopharma GmbH; Fort Lee (NJ); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. seeks a Senior Director, Laboratory to lead high-volume testing and donor screening, ensuring regulatory compliance and performance across multiple sites.

This executive role reports to the Global Plasma CEO and shapes strategic direction, quality, and operational excellence. You will oversee budgeting, staffing, training, and the implementation of new testing protocols while driving continuous improvement and data-driven decision making in a global plasma operations

Qualifications

• Bachelor's degree in Science, Medical Technology, Microbiology, or related discipline required.
• Master's degree preferred.

Responsibilities

• Provide strategic leadership for multi-site laboratory operations.
• Ensure compliance with FDA, CLIA, ISO, AABB, EU, cGLP, OSHA standards.
• Drive continuous improvement and operational efficiency across labs.
• Oversee budgets, forecasting, and financial performance.
• Develop and lead high-performing laboratory leadership teams.

Skills

Strategic leadership

Regulatory knowledge

Operational excellence

Budget management

Stakeholder engagement

Education

Bachelor's degree

Master's degree preferred

Tools

LIMS

Job description

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.

Job Summary

Shape the future of plasma laboratory operations on a global scale. We are seeking a Senior Director, Laboratory to provide strategic and operational leadership for high-volume laboratory testing, including infectious disease screening, donor acceptability testing, serology, nucleic acid testing, specialty testing, and outsourced laboratory services. Reporting to the Global Plasma CEO, this executive-level leader will oversee end-to-end laboratory operations, drive organizational performance, ensure regulatory compliance, and lead continuous improvement initiatives across a multi-site laboratory environment. This role offers the opportunity to influence laboratory strategy, quality, innovation, and operational excellence while supporting the delivery of critical plasma-derived therapies.

What You'll Do

• 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.

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.

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary ranges are determined based on relevant experience, education, and certifications.
If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team [e-mail].

Employee Benefits:

At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:

• Health & Wellness– Full medical, dental, and vision coverage
• Financial Security– Life insurance, AD&D, and retirement savings plans
• Work-Life Balance– Paid time off, sick leave, and paid holidays
• Career Growth– Training programs and development opportunities
• Extra Perks– Employee discounts, wellness initiatives, and more!

For specific inquiries please reach out to us

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.