Jobs · Analyst

Senior Director, Laboratory

KEDPLASMA · Fort Lee, NJ · 1 mo ago
RemoteRemoteAnalystFull-time

About the role

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.

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.

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.

Benefits

  • 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!

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