Director of Clinical Laboratory Operations

NeuroKaire is a multi-award-winning biotechnology company based in New Jersey offering a new tool in the treatment of Major Depression to help patients find the best treatment for them using a precision medicine approach. Our mission is to reduce the number of patients suffering, the time patients suffer and improve the quality of patient lives. As the Director of Clinical Laboratory Operations of our clinical laboratory located in Kearny, NJ, you will play a critical role in overseeing all laboratory activities, ensuring the highest standards of quality, efficiency, and compliance. You will lead a team of skilled scientists and technicians, managing daily clinical operations, and driving continuous improvement in our laboratory processes. Your expertise in laboratory automation, cell culture, immunofluorescence assays (IFA) and other methods will be essential in advancing our patient testing capabilities.

Key Responsibilities:

Oversee the day-to-day operations of the clinical laboratory, ensuring that all activities are conducted in compliance with regulatory requirements and company standards.
Manage a team of scientists, technicians, and support staff, fostering a culture of collaboration, innovation, and continuous improvement.
Implement laboratory policies, procedures, and protocols to ensure the highest quality of work and adherence to safety standards.
Ensure the accurate and consistent performance of laboratory assays including cell culture, IFA, and DNA technologies.
Identify opportunities for process improvement and drive integration of automation, working closely with cross-functional teams to enhance laboratory workflows.
Assists with validation and implementation of new methodologies in the laboratory.
Maintain a robust quality assurance management system, ensuring accurate documentation, traceability, and adherence to SOPs.
Develop laboratory performance metrics to ensure process monitoring, efficiency, and safety.
Ensure compliance with all relevant regulatory agencies, including CLIA, NJ Department of Health and other federal and state regulatory bodies.
Monitor and manage laboratory budgets, resources, inventory, and vendors, ensuring efficient use of materials and equipment.
Collaborate with R&D, engineering, and commercial teams to align laboratory operations with company goals and product development timelines.
Communicate effectively with internal and external stakeholders, providing updates on laboratory performance, project progress, and strategic initiatives.

Qualifications

Ph.D./MS/BS in Molecular Biology, Cell Biology, Biochemistry, Clinical Laboratory Science, or a related field preferred.
At least 6-8 years of experience in clinical laboratory management, including laboratory automation, cell culture, IFA/immunoassays.
Established experience in leading and managing laboratory teams.
Proven track record with laboratory automation
Extensive experience with cell culture techniques, including stem cells reprogramming.
Expertise in immunofluorescence assay (IFA) methods, including assay development, validation, and troubleshooting.
Prior experience with DNA technologies is a plus.

Skills

Strong leadership and team management skills, with the ability to inspire and motivate others.
Excellent problem-solving and critical-thinking skills, with a focus on innovation and continuous improvement.
Strong understanding of regulatory requirements and quality assurance practices in a CLIA/CAP clinical laboratory setting.
Excellent communication skills, both written and verbal.

Benefits

Competitive salary.
Comprehensive benefits package, including health, dental, and vision insurance, 401k.
Opportunities for professional development and career advancement.
A dynamic and innovative work environment at the forefront of NeuroHealth care.

Location

On-site, Kearny, NJ

NeuroKaire (formerly Genetika+)

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Director of Clinical Laboratory Operations