Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development

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.

Requirements

• 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
• Experience working with global teams is a plus
• 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% and a vesting schedule of only 5 years
• 15 PTO days per year
• sick leave
• 11 paid holidays