This position is responsible for the operations of the CLIA laboratory within the Research and Development context of Biological Dynamics. As a CA licensed CLS, this is a hands-on role where you have the opportunity to build and develop an efficient CLIA operation to serve the clinical needs of the Company, under the leadership and guidance of the Laboratory Director. The responsibilities include bench work as needed, partnering in LIS implementation, writing SOPs and validation protocols as needed, supervising staff CLSs, accessioning staff and oversight of supply inventory. The manager will function as the primary point of contact between the staff and the Laboratory Director.
Responsibilities and Duties:
Performs and monitors clinical activities in the CLIA laboratory to ensure that acceptable levels of analytic performance are maintained, to include review of quality control, instrument and equipment maintenance, and other quality assurance activities
Ensures day-to-day supervision and management of high complexity molecular testing following established SOPs for specimen handling and processing, test analysis, reporting results and record keeping.
Performs and supervises routine and non-routine testing and assigned research projects
Participates in the design and execution of validation of assays meeting CLIA/CAP standards
Organizes and improves CLIA laboratory workflows and processes to ensure turn around time (TAT) is met
Ensures that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications
Maintains stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and immediately communicating these to senior management as necessary for prompt resolution.
Implements standard protocols, practices, procedures and techniques for effective safe operations of the diagnostic laboratory.
Writes standard operating procedures (SOPs) and participates in writing technical manuals
Verifies that CLS staff are trained and competent prior to performing testing on patient specimens independently
Oversees CLS staff, assigning work schedules and priorities
Participates in hiring, training and evaluation annual performance of CLS
Documents and alerts Laboratory Medical Director to unresolved problems
Shipping & Receiving
Manages the Safety, Accessioning & Receiving Specialist by providing direction on specimen accessioning intake and shipping/receiving/distribution procedures
Supports continuous improvement of processes in this area
B.A. or B.S. in medical technology or biological sciences from an accredited
college or university.
3 to 5 year's direct experience in a clinical laboratory setting with expertise in one or more of the following:
o Extraction of nucleic acids (DNA & RNA) from body fluids (e.g. whole blood)
o Polymerase Chain Reaction (PCR) analysis of sequence variation in genomic DNA
o Real-time Quantitative PCR (RT-qPCR) expression analysis of RNA
o Genomic DNA sequencing, either traditional Sanger or Next Generation Sequencing is a plus
o Experience in CLIA lab operations
Current California state Clinical Laboratory Scientist license to perform laboratory testing.
Working knowledge of the operation and maintenance of pipettes, pH meters, balances, centrifuges and other standard or specialized laboratory equipment preferred.
Knowledge of medical terminology and standard diagnostic laboratory protocols
Ability to communicate clearly in person, on the phone, and in writing and establish /maintain cooperative relationships with staff and others.
Demonstrated proficiency in computer skills such as word processing, statistical analysis, and laboratory information systems.
Ability to supervise a small team as well as to work independently as required