Principal Scientist, Cdx Ihc Development

Systimmune Inc

Redmond, WA, United States
Base: $130,000 - $160,000 annually; bonus/equity: ...
On-site
Ihc assay development and validation
Cdx regulatory submission experience
Design control and qms compliance
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in innovative cancer treatments using advanced biologics platforms

Job Summary

  • SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in innovative cancer treatments using advanced biologics platforms.
  • The Principal Scientist will provide hands-on scientific leadership for CDx IHC assay development from early feasibility through regulatory submission and commercialization readiness.
  • SystImmune offers a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, a 401(k) plan with company match, PTO, sick leave, and paid holidays.

Matching Summary

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in innovative cancer treatments using advanced biologics platforms.

Salary

Base: $130,000 - $160,000 annually; Bonus/Equity: Not specified; Benefits: Comprehensive benefits including medical/dental/vision premiums paid, 401(k) with match, PTO, sick leave, and holidays

Skills & Requirements

Must-have

  • IHC assay development and validation
  • CDx regulatory submission experience
  • Design control and QMS compliance
  • Collaboration with pathology and clinical teams
  • Oncology biomarker development
  • Analytical validation strategy leadership

Nice-to-have

  • Experience with approved or late-stage CDx programs
  • Interacting with global health authorities
  • Mentoring and team leadership
  • Cross-functional stakeholder collaboration

Key Requirements

  • PhD in Pathology, Immunology, Molecular Biology or related field
  • 8–12+ years industry experience in CDx or biomarker assay development
  • Strong knowledge of 21 CFR Part 820 and ISO 13485
  • Experience supporting clinical trials and CDx regulatory submissions
  • Understanding of IHC scoring methods (TPS, CPS, H-score)

Work Rights

Not specified

Tailored Resume

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