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At MSK, new scientific findings are readily translated into diagnostic procedures through IHC analyses. There is the need for rapid yet accurate generation of new and robust IHC protocols in a CLIA compliant fashion. The Department of Pathology has three separate laboratories, which perform IHC procedures:

(1) The development IHC lab, which develops all novel primary reagents and IHC procedures which are implemented in other IHC labs, including the development and validation of CLIA compliant LDTs (Laboratory Developed Tests) for the clinical IHC

(2) The clinical IHC lab, which performs IHC analysis in a CLIA setting serving the diagnostic needs of the departments pathologist faculty

(3) The IHC core facility, which performs non-CLIA compliant immunohistochemical analysis as a paid service and in a research setting.

New CLIA-compliant IHC protocols need to be established first in the developmental IHC lab, then implemented in the clinical IHC lab with simultaneous availability in the IHC core lab for research purposes. The Assistant Manager of IHC Development unites and oversees the technical operation of all three immunohistochemical laboratories, under the direction of and in close collaboration with of the Director of Immunohistochemistry, IHC Medical Director, and Department of Pathology Chair, working closely with the surgical pathology laboratory manager, clinical IHC supervisor, Pathology Core Lab Head, and Director of IHC.

The Assistant Manager of IHC helps to formulate and implement strategic directions and goals for the operation and development of IHC-based techniques based on the analysis of current operations, anticipated needs, financial considerations, and innovative approaches. This role provides strategic and technical direction and leadership in defining and achieving IHC objectives while ensuring compliance with regulatory agencies. The Assistant Manager of IHC is responsible for the daily operations of the IHC development lab while coordinating the efforts of the CLIA and core labs to provide unified workflows and technical approaches across the pathology department.

The position oversees the development of novel assays for both research and clinical practice, ensuring consistency of quality across multiple platforms while helping to pursue the department's scientific projects and mission, including R&D activities, and clinical trial activities to advance the growth of immunohistochemistry at MSKCC.

You Will:

• Work with the IHC Medical and Director of IHC in formulating and implementing the short and long-range goals for the operation and growth of IHC; set priorities, assign responsibilities, and establish timetables.
• Maintains responsibility for the overall technical planning and operations of IHC activities.
• Serves as main operational lead for the technical aspects immunohistochemistry across the Pathology Departments IHC labs.
• Proactively participates in discussions with Laboratory leadership and Department Administration.
• Ensures the harmonization of IHC protocols across Department of Pathology IHC labs.
• Manages technical aspects of collaborations with industry, including preclinical evaluation of novel companion diagnostics, in concert with Scientific Director of IHC.
• Creates and implements standard operating procedures to prepare for laboratory accreditation.
• Support development of next generation IHC-based tests by providing guidance and technical leadership to key stakeholders.
• Project future needs and formulate strategies consistent with projections.
• Optimizes workflows and productivity within the clinical lab, development lab, and core lab.
• Implements proper recording of protocols and activities in developmental and core IHC labs,
• Develops the budget for IHC development lab (e.g., laboratory supplies, capital expenditures, salaries)
• Oversee the management of cross-functional teams in the development and production of IHC.
• Take responsibility for employee development including technicians and all levels of scientists and faculty in the laboratory.
• Provides technical support in biomarker assay development, including discovery and validation of biomarker targets, experimental design, data analysis, and coordination of lab activities as well as the transfer of products to operations in the CLIA lab and core labs.
• Identifies, and assists Director of IHC in characterization and development of novel diagnostic products for the institution.
• Conduct feasibility studies.
• Serve as technical expert in discussions with pharma, clinical trial, physician, regulatory and other partners and collaborators to guide clinical study design for assay utilization.
• Lead relevant biomarker/ CDx performance metrics content in accordance with SOPs, CLIA/CAP, GLP, and/or other regulatory guidance as appropriate for submission documents.
• Maintain a strong understanding and awareness of new and emerging technical developments in the field of IHC.
• Engage in new technology identification and evaluations, including multiplexed IHC, digital image analysis, deep learning and other emerging technologies critical to the continued scientific leadership of MSK.