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Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development
SystimmuneUnited Statesfull_timeVerifiedPosted 15 Apr 2026
💰 $140,000/yr($90,000/yr – $140,000/yr)
About the role
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking a Scientist or Senior Scientist to lead and support immunohistochemistry (IHC) assay development for companion diagnostic (CDx) kits supporting oncology drug development. This role is responsible for end-to-end IHC assay development, including antibody selection, assay optimization, analytical validation, and clinical trial implementation, with a clear development path from RUO/LDT to IVD CDx commercialization.
The ideal candidate has strong expertise in pathology, IHC assay development, and CDx regulatory expectations, and can work effectively across R&D, clinical, regulatory, QA, and external CROs and central laboratories.
Key Responsibilities
IHC Assay & CDx Development
Analytical Validation & Performance
Clinical Trial & Central Lab Support
Qualifications
Education
Experience
We are seeking a Scientist or Senior Scientist to lead and support immunohistochemistry (IHC) assay development for companion diagnostic (CDx) kits supporting oncology drug development. This role is responsible for end-to-end IHC assay development, including antibody selection, assay optimization, analytical validation, and clinical trial implementation, with a clear development path from RUO/LDT to IVD CDx commercialization.
The ideal candidate has strong expertise in pathology, IHC assay development, and CDx regulatory expectations, and can work effectively across R&D, clinical, regulatory, QA, and external CROs and central laboratories.
Key Responsibilities
IHC Assay & CDx Development
- Lead development of IHC-based CDx assays, from biomarker discovery through assay optimization and validation.
- Select and evaluate primary antibodies, detection systems, and staining platforms (e.g., Ventana, Dako, Leica).
- Optimize assay parameters, including epitope retrieval, antibody dilution, detection chemistry, and staining conditions.
- Establish scoring algorithms, cut-off strategies, and interpretation guidelines in collaboration with pathologists.
- Support biomarker strategies for patient selection and stratification in clinical trials.
Analytical Validation & Performance
- Design and oversee analytical performance studies, including:
- Sensitivity and specificity
- Precision and reproducibility (intra-run, inter-run, inter-site)
- Accuracy and robustness
- Linearity and limit of detection, where applicable
- Prepare, review, and approve validation protocols, reports, and SOPs in alignment with CDx expectations.
Clinical Trial & Central Lab Support
- Support implementation of IHC assays in clinical trials, including:
- Central laboratory qualification and oversight
- Pathologist training and alignment
- Slide logistics, staining consistency, and scoring harmonization
- Collaborate with clinical teams on sample strategy, feasibility studies, and biomarker cut-off justification.
- Regulatory & Quality Collaboration
- Work closely with Regulatory Affairs and Quality Assurance to ensure compliance with:
- FDA CDx guidance (US)
- NMPA/CDE requirements (China), where applicable
- IVDR (EU), as relevant
- Support preparation of regulatory documentation, including:
- IDE/IND biomarker sections
- CDx bridging strategies (RUO/LDT → IVD)
- Analytical and clinical performance summaries
- Ensure assay development aligns with QMS requirements, design controls, and document traceability.
Cross-Functional & External Collaboration
- Serve as a technical subject-matter expert, interacting with:
- CROs, central laboratories, and IVD partners
- Antibody vendors and staining platform providers
- Provide scientific input to project teams, governance meetings, and external collaborations.
- Mentor junior scientists and contribute to team capability building, as appropriate.
Qualifications
Education
- PhD in Pathology, Molecular Biology, Immunology, Oncology, or a related field
- MS or BS with significant CDx or IVD industry experience may be considered
Experience
- 3–5+ years of hands-on experience in IHC assay development, preferably in a CDx o
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