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Sr. Scientist I/II - Pathology Assay Development

$115.6k - $176.3k

MacroGenics

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 150+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.Summary of PositionThe 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.Responsibilities and Job DutiesTissue-Based Assay Development• 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.Digital Pathology and Image Analysis• 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.Translational Biomarker Support• 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.External Partnerships and Assay Transfer• 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.Documentation, Quality, and Laboratory Operations• 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.Qualifications Education & CredentialsSr. Scientist IIPhD in pathology, cancer biology, immunology, molecular biology, biomedical science, or a related discipline with 3+ years of relevant industry experienceMS with 8+ years of relevant industry experience.BS with 11+ years of relevant industry experience.Sr. Scientist IPhD in pathology, cancer biology, immunology, molecular biology, biomedical science, or a related discipline with 0+ years of relevant industry experienceMS with 5+ years of relevant industry experience.BS with 8+ years of relevant industry experience.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.Preferred• 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.Additional InformationThe annual rate of pay for this position ranges from $115,600 - $176,300 for Scientist II and $100,800 - $153,800 for Scientist I. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company’s benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits. The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email View email address on click.appcast.io or call View phone number on click.appcast.io and/or 711 for TTD/TTY service. Job SummaryRequisition Number: SRSCI001924Job Category: ResearchSchedule: Full-Time

Vacancy posted 9 hours ago
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