Clinical Lab Manager

Company Description

BioCytics Inc is located in Huntersville, NC. BioCytics was founded by Dr. John Powderly, MD, a board-certified oncologist and president of Carolina BioOncology Institute (CBOI). BioCytics, Inc.’s mission is to directly apply living cells in clinical trials as affordable individualized immune cellular therapies manufactured at the Point of Care (PoC). It is the only independent, privately held, warm-chain PoC cellular manufacturing facility in the US and is co-located with Carolina BioOncology Institute, PLLC (CBOI) Phase 1 Clinical Trials research center.

Role Description

This is a full-time, on-site role as a hands-on Clinical Lab Manager at BioCytics Inc in Huntersville, NC. The hands-on aspect means they are often and routinely involved in the practical, technical aspects of the lab, not just administrative tasks.  As a Clinical Lab Manager, you will be responsible for the day-to-day operations of our clinical lab and biorepository / biobank, and working with our GMP manufacturing team. This includes all phases of preanalytical, analytical, and post-analytical work, as well as seamlessly interfacing with other departments. The lab manager is responsible for ensuring the quality and integrity of work performed from sample collection, processing, and analysis to reporting, while ensuring compliance with research protocols and CLIA / COLA regulations, maintaining laboratory equipment, supervising lab staff and performing hands-on routine testing, cell processing and GMP product manufacturing . You will work closely with the research team, including scientists and physicians, to support ongoing clinical trials and contribute to the development of personalized oncology treatments in the Human Applications Lab.

Qualifications

• Bachelor's degree or higher in clinical laboratory sciences, chemistry, biology, immunology or equivalent.
• Certification as a Medical Laboratory Scientist (or equivalent) by a nationally recognized board / agency (ex, ASCP, AAB, AMT).
• At least four (4) years of working experience as a Medical Technologist in a full-service high-complexity clinical laboratory. At least 1 year of flow cytometry and immunology experience. Supervisory experience preferred.
• Previous experience in a clinical laboratory and biorepository / biobank, preferably in oncology research or related field. GMP manufacturing experience is a plus.
• Strong knowledge of laboratory techniques and procedures, including clinical chemistry, hematology, immunology and flow cytometry.
• Experience with quality assurance and quality control practices in a laboratory setting.
• Experience with laboratory inspections, and full understanding of CLIA regulations.
• Experience with biobanking according to ISO 20387 and AABB cellular therapy standards.
• Familiarity with regulatory requirements and compliance standards for clinical research (e.g., IRB, FDA).
• Excellent organizational, communication, and leadership skills are required.
• Ability to work effectively in a team and collaborate with cross-functional stakeholders.
• Attention to detail and ability to manage multiple responsibilities, tasks and deadlines.
• Proficiency in relevant computer software and data management systems.

Job Summary

This position reports directly to the Clinical Laboratory Director. The Laboratory Manager is responsible for the daily operations, administration, technical supervision and management of human and financial resources of the clinical laboratory, including flow cytometry, biorepository / biobank and cross-functional service with the GMP manufacturing unit .  This is a working manager position including routinely performing hands-on laboratory testing.

Ensures compliance with COLA / CLIA, CMS, HIPAA, FDA, ISO 20387, AABB cellular therapies and other regulatory agencies and laws governing laboratory services. Ensures implementation and administration of department quality program. Directs, supports, and promotes continuous improvement of quality and services.

Skills and Abilities

Demonstrated competency in high-complexity clinical laboratory skills including but not limited to quality control, proficiency testing, automated testing systems, hematology manual differential, urine microscopy, immunology assays, flow cytometry, general chemistry and molecular diagnostic testing. Ability to adapt to accreditation / regulatory changes in the laboratory industry. Robust experience in biobanking / biorepository standards and in practice. Ability to analyze data, draw conclusions and interpret results. Ability to communicate effectively, both orally and in writing. Ability to demonstrate responsibility, dependability, and professionalism. Ability to maintain inventory control systems and make budgetary projections. Ability to organize, prioritize, multi-task, and adapt to changing priorities. Ability to provide excellent customer service. Ensures laboratory coverage on a day-to-day basis. Ability to solve problems and identify solutions. Ability to train, orient, and evaluate the job performance of new employees and students. Ability to work effectively with individuals at all levels of the organization. Physical and other Requirements Occasional light lifting is expected. Ability to sit / stand for extensive periods of time. Key skills include supervision / management, coaching, prioritization and management of multiple tasks, good written and oral communication, record keeping, time management, self-motivation / drive, excellence, efficiency, productivity and teambuilding. Establish and maintain effective working relationships with coworkers, managers and clients. Rotates in clinical lab, biobank and GMP manufacturing.