Sr. Scientist I/II - Pathology Assay Development
MacroGenics, Inc.
Summary
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.
Job description
Responsibilities and Job Duties
Tissue-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.
Requirements
- 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 II)
- 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 (Sr. Scientist I)
- 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
Benefits
- Medical, Dental & Vision
- Prescription Coverage
- Employee Wellness Resources
- 401(k) Matching
- Employee Stock Purchase Plan
- Paid Time Off
- Paid Parental Leave
- Disability Benefits
- Discretionary Bonus
- Discretionary Equity Incentives
Company overview
MacroGenics, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The company leverages its proprietary antibody-based technology platforms to create novel product candidates that target various cancer types. MacroGenics has developed several proprietary platforms including DART® (Dual-Affinity Re-Targeting) technology, which enables the creation of bispecific antibodies that can simultaneously bind to two different antigens. The company's pipeline includes multiple clinical-stage candidates targeting hematologic malignancies and solid tumors. MacroGenics' lead product candidate, margetuximab, is an Fc-optimized monoclonal antibody targeting HER2, which has shown promise in breast cancer and gastric cancer. The company collaborates with various pharmaceutical partners to advance its pipeline and has established itself as a leader in the field of antibody engineering and cancer immunotherapy.