Sr. Scientist I/II - Pathology Assay Development

MacroGenics•Rockville, MD

5d•Onsite

About The Position

The Sr. Scientist I/II - Pathology Assay Development will lead the development, optimization, qualification, troubleshooting, and transfer of tissue-based biomarker assays supporting MacroGenics' antibody-drug conjugate (ADC) and immunotherapy programs from discovery through IND-enabling studies and early clinical development. The role will focus on single-plex and multiplex immunohistochemistry (IHC), immunofluorescence (IF), in situ hybridization (ISH), digital pathology, and fit-for-purpose tissue biomarker workflows. The Sr. Scientist I/II will work closely with the Senior Director of Pathology and cross-functional partners to generate robust, reproducible, and biologically meaningful tissue biomarker data that informs target selection, patient-selection hypotheses, translational strategy, safety assessment, and development decisions. Final pathologic interpretation, tissue biology assessment, and clinical-contextual interpretation will remain under pathology leadership.

Requirements

Sr. Scientist II PhD in pathology, cancer biology, immunology, molecular biology, biomedical science, or a related discipline with 3+ years of relevant industry experience
Sr. Scientist II MS with 8+ years of relevant industry experience.
Sr. Scientist II BS with 11+ years of relevant industry experience.
Sr. Scientist I PhD in pathology, cancer biology, immunology, molecular biology, biomedical science, or a related discipline with 0+ years of relevant industry experience
Sr. Scientist I MS with 5+ years of relevant industry experience.
Sr. Scientist I BS with 8+ years of relevant industry experience.
Demonstrated hands-on expertise developing and troubleshooting tissue-based biomarker assays, particularly IHC and/or multiplex IF, in a biotechnology, pharmaceutical, academic, diagnostic, or CRO environment.
Strong working knowledge of FFPE and frozen tissue handling, antibody performance, assay controls, and common sources of staining artifact.
Experience designing fit-for-purpose assay qualification or validation studies and defining objective assay acceptance criteria.
Experience with digital pathology and image-analysis platforms such as HALO, QuPath, Visiopharm, or comparable software.
Ability to independently analyze experimental data, troubleshoot complex technical problems, document conclusions, and recommend next steps.
Strong scientific writing, presentation, organization, and cross-functional communication skills.

Nice To Haves

Experience developing multiplex IHC/IF, ISH, spatial biology, or image-analysis assays for oncology drug development.
Experience supporting ADC, immuno-oncology, bispecific antibody, or T-cell engager programs.
Experience with automated staining platforms and workflows, including Ventana/Roche, Leica, or comparable systems.
Experience with assay transfer, vendor oversight, clinical biomarker testing, or work performed in regulated or quality-controlled environments.
Familiarity with AI/ML-enabled digital pathology, computational image analysis, or integration of tissue imaging data with molecular and clinical datasets.
Formal training or substantial experience in pathology, histotechnology, tumor morphology, or tissue-based translational research.

Responsibilities

Independently develop, optimize, qualify, validate, and troubleshoot single-plex IHC, multiplex IHC/IF, and ISH assays using FFPE and frozen tissues.
Design fit-for-purpose assay development plans, including antibody and reagent selection, titration, antigen retrieval, detection chemistry, controls, acceptance criteria, and reproducibility assessments.
Evaluate assay specificity, sensitivity, dynamic range, precision, robustness, and tissue-context performance using appropriate positive, negative, isotype, cell-line, xenograft, and normal-tissue controls.
Identify and resolve pre-analytical and analytical variables related to tissue collection, fixation, processing, sectioning, storage, staining platforms, and reagent performance.
Develop and maintain tissue and cell-pellet control resources to support assay development and routine assay performance monitoring.
Translate exploratory assays into qualified biomarker workflows suitable for nonclinical and clinical research applications.
Perform whole-slide image review, quality control, and quantitative analysis of tissue biomarker data.
Partner with pathology leadership to ensure that digital outputs are morphologically appropriate, analytically sound, and aligned with the intended biological question.
Evaluate and implement digital pathology tools and, where appropriate, AI/ML-enabled image-analysis approaches.
Execute tissue-based components of translational biomarker strategies defined with Pathology and Translational Medicine leadership.
Generate target-expression, pharmacodynamic, mechanism-of-action, and tumor-immune microenvironment data across preclinical models and clinical specimens.
Prepare publication-quality images, quantitative summaries, data visualizations, and technical interpretations for internal project teams, governance discussions, reports, and regulatory-supporting documents.
Coordinate assay development, qualification, validation, and sample testing with external CROs and central laboratories.
Draft technical scopes of work, review protocols and validation plans, monitor study execution, assess data quality, and troubleshoot technical issues with vendors.
Lead or support assay transfer, method bridging, and cross-site concordance activities to ensure consistent performance across internal and external laboratories.
Author and maintain assay development reports, validation summaries, SOPs, work instructions, protocols, templates, and technical best practices.
Maintain organized assay records, raw data, digital image libraries, annotations, reagent inventories, and reference materials in accordance with applicable quality and data-integrity expectations.
Support platform evaluation, laboratory workflow improvement, and adoption of new tissue-based biomarker technologies.
Ensure timely delivery of high-quality data while managing multiple assays, program priorities, and vendor activities.