Director of Laboratory Operations - Simply Biotech

Director of Laboratory Operations - Simply BiotechOVERVIEWAre you looking for a new opportunity to join an exciting multinational healthcare company that provides actionable genomic information to personalize the diagnosis and treatment of cancer as a key member of their coveted Executive Lab Ops team? In this role, you'll be responsible for management of the diagnostics laboratory that includes managing laboratory personnel, conducting, and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting lab results as well as plans and directs assay transfer project, facilitates IT system verification and validations testing, coordinates with equipment transfers and reagents transfers from Product Development. This position will take charge of execution of major multi-disciplinary optimization and validation projects. Our client is a market leader in the important and growing field of molecular diagnostics, is growing again fast, and is offering top market comp, excellent fully paid healthcare benefits for employees, and progressive career opportunities! Immediate opening for a Director of Laboratory Ops near Dallas, TX who possesses:-Degree-8-10 years of related work experience, with in-depth management experience -Experience with LIMS database, ISO quality management systems, and OSHA compliance.-Real-time PCR, DNA/RNA extraction, IVD manufacturing, and lab automation (specific)-Management in personalized medicine/molecular diagnostics and CLIA/CAP/NY lab services-Ability to manage and develop people in a cross-functional teamwork environment -Experience in validating and launching molecular diagnostic tests-Experience working with Urine and Blood as diagnostic sample types including troubleshooting and optimization with the isolation and extraction of nucleic acids. -Any microbiology experience Please send your resume to mturner@(858) 356-6772 RESPONSIBILITIES INCLUDE:-Consult with the Laboratory Operations Management regarding the workflow of the clinical laboratory and revisions of laboratory general standard operating procedures.-Manages laboratory personnel.-Able to analyze department capacity, budgets, reagents inventory and headcount projection and provide continuous improvement ideas to Laboratory Operations Management.-Oversees the scheduling of laboratory personnel to ensure the workflow is being efficiently implemented.-Provides technical oversight to laboratory personnel on the more difficult and problematic areas.-Responsible for project transfer project from IT and/or Product Development to Laboratory Operations. Communicates with staff within department or across different departments to maintain and facilitate deadlines.-Ensures the Equipment team is performing all preventive maintenance and calibration tasks and the documentation is completed within the established timeframe.-Oversees the automated laboratory instrumentation that includes troubleshooting, preventive maintenance and repair procedures as required.-Responsible for the oversight of the Secure company Laboratory Information Management Systems (LIMS) daily, identifying future enhancements, and validation activities.-Responsible for maintaining up-to-date laboratory general standard operating procedures.-Manages laboratory personnel to ensure that they are applying problem solving skills; knowledgeable of the molecular and microbiology processes and uses organizational skills to meet established turnaround time deadlines.-Responsible for the oversight of accurate documentation using good documentation practices of clinical diagnostic testing activities including but not limited to patient specimens, proficiency testing (preanalytical), transcribing quality control results, performance of preventive maintenance, calibration of instruments, and LIMS results entry.-Responsible for identifying, reporting, and documenting laboratory operations nonconformances and works under the direction of the Quality Systems Department and the Laboratory Director in the process of initiating a CAPA, performing an investigation, identifying the root cause and implementing corrective action.-Ensures laboratory personnel maintain on a daily basis, a neat, clean, well-organized laboratory area including adequate daily working supplies stocked/stored.-Oversight of inventory of supplies and ensure that reagents and supplies are labeled and stored at required temperatures and locations. -Responsible for contacting suppliers regarding shipment status, backorders, packing slips for laboratory reagents and scheduling equipment for repairs or preventive maintenance.-Oversight of training and cross-training of laboratory personnel.-Responsible for the oversight of the competency assessment program is completed for laboratory personnel (biannually for new employees employed less than one year) as scheduled.-Responsible for meeting or exceeding results for key performance indicators and quality metrics.-Identify and implement continuous process improvement.-Responsible for ensuring training programs are developed, implemented, and are current.-Adapt to changes in processes, accepting approved changes and learning new tasks.-Participate in conducting and attending continuing education programs (mandatory and non-mandatory).-Establishes a learning environment that encourages mentoring and coaching.-Follow processes under the Quality Management Systems for CAPA, Deviations, Nonconforming Materials and Client Complaints.-Participate as a member of the Internal Audit Team for the current ISO certification, New York State Department of Health, and the College of American Pathologists.-Participate as a CAP qualified external auditor for the company College of American Pathologist inspection team as required by the College of American Pathologists accreditation program, where needed.-Keeps abreast of all Laboratory Industry Standards and regulatory requirements for New York State Department of Health, College of American Pathologists, International Organization of Standardization (ISO), and Centers for Medicare and Medicaid Services).-Responsible for ensuring that direct reports are completing assigned tasks in MasterControl within the required timeframes.-Responsible for completing assigned tasks in MasterControl within the required timeframes.