• Posted on: May 09, 2023
  • Location: Plainsboro, NJ
  • Job ID: f57bd0ce
  • Type: Full Time
  • Category: Executive
  • Posted on: May 09, 2023
  • Location: Plainsboro, NJ
  • Job ID: f57bd0ce
  • Type: Full Time
  • Category: Executive

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We are seeking a Technical director of Molecular Pathology to lead the tissue staining and other related techniques. This position will report to the CSO.
Duties Will Include the Following:
  • Build and oversee immunohistochemistry (IHC), immunocytochemistry (ICC) and in-situ hybridization (ISH/FISH/CISH) function at 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 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.
  • Work with internal and external operation groups to coordinate activities such as sample management, analysis and result reporting in real-time or in batches.
  •  Manage the budget and resources for the overall department.
  •  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.
  • 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.