SystImmune · 23 hours ago
Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development
Redmond, WA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $140K/yr
3+ years expSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. They are seeking a Scientist or Senior Scientist to lead and support immunohistochemistry (IHC) assay development for companion diagnostic (CDx) kits supporting oncology drug development, with responsibilities that include assay development, analytical validation, and clinical trial support.
BiopharmaBiotechnologyProfessional Services
Responsibilities
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
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
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
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
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
Qualification
Required
PhD in Pathology, Molecular Biology, Immunology, Oncology, or a related field
MS or BS with significant CDx or IVD industry experience may be considered
3–5+ years of hands-on experience in IHC assay development, preferably in a CDx or IVD setting
Direct experience supporting oncology biomarkers and clinical trials
Experience across the CDx development lifecycle (RUO/LDT through IVD readiness)
Strong understanding of IHC scoring methodologies (e.g., TPS, H-score, CPS)
Familiarity with analytical validation and regulatory expectations for CDx
Demonstrated ability to work effectively in cross-functional teams
Strong scientific rigor with excellent documentation and data interpretation skills
Ability to operate in a fast-paced, matrix environment
Clear and effective communication with both technical and non-technical stakeholders
Preferred
Prior experience with late-stage or FDA-approved CDx programs
Experience developing and justifying biomarker cut-off strategies
Familiarity with NSCLC, GI cancers, or other solid tumors
Experience interacting with health authorities or supporting regulatory meetings
Benefits
100% paid employee premiums for medical/dental/vision
STD
LTD
401(k) plan with a 50% company match of up to 3%
Vesting schedule of only 5 years
15 PTO days per year
Sick leave
11 paid holidays
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Company
SystImmune
SystImmune is a biotechnology company.
51-200 employees
H1B Sponsorship
SystImmune has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2023 (1)
2022 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Martin S. Olivo, MD, MSc,
Chief Medical Officer
Recent News
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