Supervisor, Laboratory
ICON plc · Farmingdale, NY · 2 wk ago
Management$104k–$125k/yrFull-time
About the role
ICON plc is a Contract Research Organization (CRO) that provides outsourced clinical laboratory, research, and regulatory services to pharmaceutical, biotechnology, and medical device companies running clinical trials. Unlike a hospital laboratory, our work is not focused on diagnosing or treating individual patients. Instead, we are the analytical backbone of global drug development: every specimen we process, every result we report, and every QC decision we make contributes directly to the safety monitoring of clinical trial subjects, as well as the pharmacokinetic, biomarker, and efficacy data that will one day reach regulatory agencies like the FDA.
What You Will Do
- Oversee daily operations across four testing disciplines within our Hematology department, including Hematology, Urinalysis, Coagulation, Hemoglobin A1c testing.
- Manage, mentor, and develop laboratory staff, including training on instrumentation, SOPs, and quality standards.
- Maintain compliance with CLIA, CAP, NYS, and sponsor-specific requirements across all testing areas.
- Oversee quality control performance, instrument maintenance schedules, preventive maintenance, and troubleshooting on Sysmex, Novus, Stago, and Trinity Biotech platforms.
- Review and approve QC data, ensuring out-of-control events are properly investigated and documented.
- Collaborate with cross-functional teams to resolve specimen-related issues and support clinical trial deliverables.
- Contribute to SOP authorship, review cycles, and appendix maintenance for supervised testing areas.
- Support proficiency testing, external quality assurance, bi-monthly studies, and regulatory inspection readiness.
- Track and report section-level turnaround time (TAT) performance, flagging exceptions, and implementing corrective actions.
- Participate in cross-site harmonization initiatives.
Required qualifications
- New York State license as a Medical Laboratory Scientist (Clinical Laboratory Technologist) required.
- MLS(ASCP) or equivalent national certification preferred.
- Bachelor's degree in Clinical Laboratory Science, Medical Technology, or related scientific discipline.
- Minimum 3-5 years of clinical laboratory experience with direct supervisory or lead responsibility.
- Hands-on experience with hematology, coagulation, urinalysis, and/or HbA1c testing strongly preferred.
- Working knowledge of CLIA, CAP, and NYS laboratory regulatory requirements.
- Strong organizational skills with the ability to manage staff, workload, and priorities simultaneously.
- Excellent communication skills and ability to collaborate across functional teams.
- Experience in a CRO, clinical trials, or pharmaceutical laboratory environment a plus.
What ICON can offer you
- Variety of annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others