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Labcorp Oncology / OmniSeq, Inc. is seeking a molecular pathologist, with significant Next Generation Sequencing (NGS) experience to perform molecular pathology responsibilities as an Laboratory Director / Associate Director in a CAP/CLIA/ISO-certified molecular diagnostic laboratory. The individual will be responsible for the development and continued implementation of the laboratory diagnostics in neoplastic specimens focused on targeted gene panels from fixed patient-derived tumors. The candidate is expected to have ongoing and substantial experience in the NGS technology, regulatory requirements, and creation of clinical reporting, bioinformatics and administration of a molecular diagnostic laboratory. The position also requires experience in the direction of medical technologists and assistants with oversight by clinical laboratory supervisory staff. Outstanding opportunities exist for collaborative, translational research with members of R&D and bioinformatics departments.
Primary responsibility includes planning, organizing and directing the overall operation of the clinical laboratory in conjunction with the Laboratory Director. Ensure that testing services are of the best quality, are cost contained and are carried out in an expeditious manner. Responsibilities include tissue quality control review, IHC review and sign out, and sign out of NGS testing. Responsible for maintaining efficient and effective good laboratory practice in compliance with all state, federal, and local regulatory laws, standards and protocols. Participates in validations and R&D activities, to include pharmaceutical services research. Licensed physician with experience and training in anatomic and clinical pathology is required. Experience and/or training in molecular pathology/biology, and board Certification or eligible in Molecular Genetic Pathology or equivalent are also required.
Assistant Laboratory Director will be overseeing a team of ~15 NYS licensed technologists as well as participating in R&D activities with the R&D scientists.
Responsible for assisting Laboratory Director in the overall operation and administration of the laboratory. Provide effective and efficient administrative direction of the laboratory, including budget planning, and controls in conjunction with other laboratory supervisory staff.
The Assistant Laboratory Director, as designated by the laboratory director, must be accessible to the laboratory as needed for on-site, telephone, or electronic consultation and is responsible for the technical and scientific oversight of the laboratory.
Support the Laboratory Director on planning, managing and ensuring compliance with all local, state and federal regulations.
Supports the Laboratory Director on Laboratory licensure and accreditation.
Provide leadership and oversight to the implementation of corrective action plans to deficiencies that may be identified through accrediting and regulatory site inspections.
Perform diagnostic interpretation and electronic release of the significance of test findings with pertinent information.
Responsible for training, proficiency and clinical sign out of NGS panel assays falling under Assistant Laboratory Director's Certificate(s) of Qualification with New York State.
Provide laboratory support for anatomic pathology / histology, review slides for pharma services and analytical validations.
Evaluation of H&E and IHC stained tumor histology on glass slides or digital images.
Analyze and respond to medical and pathology-related inquiries from clients.
Resolution of technical problems and ensuring that remedial actions are taken.
Responsible for reporting of test results with accuracy under the permit categories where the individual holds Certificate of Qualification.
Initiate and actuate improved methods of services and direct their implementation.
Communicate appropriately and clearly to physicians, staff and administration.
Build effective relationships with referring physicians and ensure excellent client follow up on reported cases.
If required, assesses CLIA-required competency for laboratory director.
Initiate, interpret and enforce Laboratory Services procedures and maintain and interpret company policies and procedures.
Cooperate in planning programs and safety and preparedness for fire and disaster.
Provides guidance and oversight during the detailed design, optimization, validation, test and production phases of new clinical tests; including selection of test methodology, reviews all test designs, methods, results and conclusions where applicable. Establishment or verification of laboratory test performance specifications.
Participate in presentations at national scientific meetings and in preparing publications for submission to peer-reviewed journals.
MD or MD/PhD with Board Certifications (or eligible) in Molecular Genetic Pathology (or equivalent), and Anatomic Pathology required.
Medical License in the State of New York; Certificate of Qualification for Oncology - Molecular and Cellular Tumor Markers in the State of New York preferred.
Certificate of Qualification for Histopathology -- General in the State of New York preferred.
The equivalent of two (2) years of training/experience in a Molecular Pathology/Biology laboratory