Share Email Opening Title Technical Director of Molecular Pathology/IHC  About the Organization Acutis (www.Acutis.com) is a specialized medical laboratory that complements its hard science with the soft skills of its support teams. This combination allows practitioners to diagnose and treat with greater confidence and with ease. At Acutis Diagnostics, we are dedicated to providing accurate and reliable clinical diagnostics services to healthcare providers, patients, and communities. As a leading laboratory specializing in toxicology testing and molecular-based PCR tests, we are committed to delivering timely and precise results that aid in patient care and treatment decisions. Founded on the principles of thorough, exact, consistent results, Acutis Diagnostics leverages cutting-edge technology and the expertise of our highly skilled team to deliver exceptional service and support to our clients. We understand the critical role diagnostic testing plays in healthcare, and we prioritize quality and accuracy in every step of our process. Whether it's toxicology screening to detect substance abuse or molecular PCR testing for infectious diseases, we strive for excellence in every test we perform. Above all, our mission at Acutis Diagnostics is to improve patient outcomes and enhance public health through advanced diagnostic solutions. We are proud to be at the forefront of clinical diagnostics, contributing to the advancement of medicine and the well-being of patients at large.   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description Technical Director of Molecular Pathology We are seeking a Technical Director of Molecular Pathology to lead the tissue staining and other related techniques at Acutis. This position will report to the CSO. Duties Will Include the Following But are Not Limited to: Build and oversee immunohistochemistry (IHC), immunocytochemistry (ICC) and in-situ hybridization (ISH/FISH/CISH) function at Acutis to develop and validate novel assays but also validate or verify off-shelf kits for offering to pharmaceutical clinical trials and standard patient care. Lead, oversee, train, manage and demonstrate to bench technologists and junior scientists to develop, optimize, and validate assays. Roll sleeves and work on the bench to help his/her team establishing an assay from commercially available raw materials, or troubleshoot a technical issue. Suggest, qualify and use materials as positive and negative quality control for each assay. Search the market or literature to elect technology and reagents for single antibody and multiplex assays based on biomarker staining pattern and purpose of an assay. Provide expert advice on biomarker selection, characterization and development for exploratory research, cancer screening or diagnostic purposes. Assess and monitor strategic position and marketplace presence of key competitors in IHC, ICC and ISH, and provide scientific input to Acutis market strategy and competitive positioning. Participate in sponsor, CRO, and investigator meetings as requested by business development team or project management. Serve as the subject-matter-expert and provide consultation and address client questions in real time. If needed, help biopharma clients in developing and implementing IHC/ISH-based biomarkers in translational or late phase clinical trials. Manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with a drug development, regulatory, and commercial strategies. Design assay development and validation plans that fit a client's purpose of an assay, draft SOPs, assay validation reports and clinical study reports. Interact with the CSO and other functions to ensure appropriate resources are established to direct assay development or assay transfer and its implementation. Provide the instructions for sample acquisition, processing, storage, shipping and handling needed for a lab manual.   Position Requirements Education PhD in one of the biological sciences with 8+ years or MS with 10+ years of experience in IHC, ISH, ICC at a CRO lab, pharmaceutical company and/or medical institution. Experience Track-records for establishing, developing, optimizing and validating novel singlet and multiplex IHC, single-probe and dual probe ISH assays in FFPE tissues – Experience in ICC and CTC phenotyping is a plus. Track-records for taking an assay from a hypothesis to utilization in clinical sample analysis with needed quality measurements. Knowledge of pharma clinical trial assay, regulatory requirements governing clinical laboratory, companion diagnostics and/or in vitro diagnostics is preferred. Experience in qPCR and dPCR is preferred. Proven ability to manage clinical translational programs and teams with minimal supervision. Self-organized and operate effectively without significant day-to-day oversight, while following the CSO high level instructions and staying connected to key stakeholders. Strong interpersonal, organization, time-management, people management, and communication skills. Collaborative and teamwork skills.   Full-Time/Part-Time Full-Time   Location Acutis BioSciences - NJ   This position is currently not accepting applications. 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