LABORATORY SUPERVISOR/MANAGER OpGen
THIS JOB HAS EXPIRED OpGen, Inc. is a leading innovator in rapid, accurate genomic and DNA analysis systems and services. The company has developed a platform, The Argus Whole Genome Mapping System and also offers MapIt? Services that provide high resolution, whole genome restriction maps for sequence assembly and finishing, strain typing and comparative genomics in the life sciences market. This proprietary de novo technology is free from the limitations of gel, PCR and sequencing-based methodologies, and expansion of Whole Genome Mapping technologies to large genomes and clinical diagnostics is currently in development. OpGen?s customers include leading genomic research centers, biodefense organizations, leading genomic research centers, academic institutions, clinical research organizations and biotechnology companies.
OpGen is committed to supporting our Customers as valued partners by creating long-term relationships and continually exceeding their expectations. OpGen employees have created the company?s success. As a result of that success, we are seeking individuals who enjoy a challenge and desire to be part of a team making a difference in healthcare outcomes.
We are seeking a Clinical Laboratory Supervisor/Manager responsible for day-to-day supervision and oversight of high complexity (both diagnostic and academic research) testing services in a Clinical laboratory environment. The Supervisor will manage routine and complex Molecular Biology procedures including training/ implementation of assays and analyzing /interpretation/reporting of test results. This individual will be responsible for supervising assigned Medical Technologists and Laboratory Associates for routine Clinical Lab Services, ensuring adherence to all regulatory standards and will be accountable for both quantity and quality of test results.
Primary Job Functions
Manage the daily operation of assigned laboratory group to ensure that specimens are properly shipped and received, tests are performed accurately and efficiently, and results are reported in a timely manner
Perform pre-analytical, analytical and post analytical test process and evaluate results generated relative to the diagnostic assessment independently and/or in coordination with Laboratory Director
Evaluate data for accuracy and verify questionable findings with proper documentation, thorough investigation, and appropriate follow-through.
Assist with designing processes and procedures to ensure efficient turn-around time and accuracy of results
Engage in continuous process and service improvement. Make and implement recommendations to improve operational efficiency and implement new services for areas of responsibility
Manage strict adherence to quality control guidelines to ensure integrity of laboratory specimens and accuracy of results
Ensure all work is in accordance with state and Federal regulations, organizational policy, and accreditation/compliance requirements
Assist in developing and securing CLIA (MD State), NYS, CAP and other accreditations
Ensure compliance with safety policies and procedures in the work area and use applicable protective equipment at all time to prevent exposure to potentially infectious agents
Coordinate training and implementation of new or revised tests and procedures, ensuring quality control in accordance with SOPs and validation performance standards
Perform duties of technologist as necessitated by absence or peak workload
Complete special projects as requested by senior staff e.g. statistical reports, studies, research, etc
Responsible for management of laboratory staff (Map-It and CLIA services) including, but not limited to, hiring, orientation, training, coaching, annual evaluations, documenting performance and disciplining to ensure a well-qualified team and to enhance operational success
Oversee Map-IT, CLIA and microbiology operations, control and coordinate all functions
Manage any and all test system deviations from established performance specifications by taking remedial actions in a timely manner
Prepare and maintain all personnel credential files to meet regulatory standards and for inspections
Coach and mentor staff on technical expertise and carry out evaluation of employee competencies
Prepare and manage laboratory budget within constraints and limitations as applicable
BS or MS in Medical Technology, Biology, Chemistry or related scientific discipline
Minimum of 5-7 yrs(BS) or 3-5 yrs(MS) related experience, 2 years at supervisory level in a clinical laboratory performing high complexity testing services
ASCP (American Society of Clinical Pathology) generalist certification or specialist in Molecular Biology (MB), Certified Medical Technologist, or equivalent license highly desired
Eligible for certification by CLIA as a Laboratory General Supervisor.
Previous molecular diagnostics experience including DNA isolation, PCR, RFLPReal-Time PCR, Capillary electrophoresis and DNA sequencing is required.
Knowledge and experience in culturing of microbes in a BSL-2 environment is required
Knowledge of regulatory requirements for molecular diagnostic test development, commercialization and post launch support is required
Experience with accreditation inspections and writing and editing laboratory Standard Operated Procedures (SOP) and policies is required
Compliance experience with regulatory agencies such as CLIA, NYS and CAP would be preferred
Operation and preventive maintenance of Lab equipment including but not limited to Thermocycler, Light cycler, Sequencing instruments, Mapping instruments etc
Demonstrated proficiency in computer skills related to laboratory information systems (LIMS)
Demonstrated proficiency in analysis software for genome related projects
Strong PC skills, including experience with Microsoft Word, Excel, PowerPoint and Outlook
Must have excellent verbal and written communication skills as well as demonstrated customer relations skills
Must be able to deal with sensitive issues effectively, maintaining confidentiality and good relationships both in the office and with employees across the company
Ability to communicate effectively and courteously with people at different levels within the organization
Ability to communicate tactfully with vendors, customers, and others seeking information, and relay their requests and information to the proper personnel effectively
Quantitative analysis skills related to assay quality metrics and performance?sensitivity, specificity, accuracy, False positive and False negative rates
Ability to create and interpret statistical data reports and/or charts on assay TAT, repeat rates, quality metrics of assay performance, etc using LIMS
Excellent leadership and organization skills.
Strong team player who thrives in a team environment and presents themselves in a polished professional manner.
Ability to work independently with flexibility and with adaptability, efficiency, accuracy and professionalism.
Strong planning and organizing skills with the demonstrated ability to multi-task, manage multiple priorities and changes in priorities with professionalism
Accountability for personal decisions, actions and results.
Must be willing to work as required for the efficient operation of the business. Must be resourceful in resolving problems.
Position may require sustained periods of standing, sitting and work using a computer monitor as well as lifting up to 25 lbs.
BSL2 laboratory environment handling human specimens of all types including infectious disease agents
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THIS JOB HAS EXPIRED