Lead CDx IHC Development Scientist

SystImmune, Inc.; Redmond (WA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Premium medical coverage

401(k) plan with company match

Paid time off

Job summary

SystImmune, Inc. in Redmond, WA seeks a Principal Scientist to lead CDx IHC biomarker development for oncology programs. This role combines hands-on assay development with strategic oversight across regulatory and quality domains.

You will steer analytical validation, platform strategies, and cross-functional collaborations with pathology, translational science, and external diagnostic partners to ensure timely regulatory submissions and commercialization readiness.

Qualifications

• PhD in Pathology, Immunology, or related field.
• 8–12+ years in CDx, IVD, or biomarker assay development.
• Proven experience leading IHC assay development and analytical validation.
• Strong knowledge of design controls and QMS (21 CFR Part 820, ISO 13485).

Responsibilities

• Lead development of CDx IHC assays and kits from early feasibility through IVD readiness.
• Define assay design, platform selection, and development strategy aligned with regulatory expectations.
• Oversee antibody selection, assay optimization, and standardization across platforms (Ventana, Dako, Leica).
• Guide development of scoring algorithms, cut-offs, and interpretation frameworks with pathology leadership.
• Lead analytical validation strategy and execution for CDx IHC assays, including sensitivity, specificity, precision, accuracy, and robustness.
• Ensure validation activities meet regulatory expectations and are conducted under design control.
• Oversee preparation and approval of validation protocols, reports, and technical documentation.
• Mentor team members and contribute to building CDx development capabilities.

Skills

CDx IHC leadership

Regulatory strategy understanding

Cross-functional collaboration

Ventana platforms

Dako platforms

Leica platforms

Education

PhD in Pathology/Immunology/ Molecular Biology

Tools

Ventana platforms

Dako platforms

Leica platforms

Job description

SystImmune, Inc. in Redmond, WA seeks a Principal Scientist to lead CDx IHC biomarker development for oncology programs. This role combines hands-on assay development with strategic oversight across regulatory and quality domains.

You will steer analytical validation, platform strategies, and cross-functional collaborations with pathology, translational science, and external diagnostic partners to ensure timely regulatory submissions and commercialization readiness.