Scientist/Senior Scientist, Companion Diagnostics (Cdx) - IHC Development SystImmune, Inc.Scientist/Senior Scientist, Companion Diagnostics (Cdx) - IHC DevelopmentRedmond, WA$90,000–$140,000 / yearThe 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. 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.
Scientist/Senior Scientist, Companion Diagnostics (CDx) – IHC Development SystimmuneScientist/Senior Scientist, Companion Diagnostics (CDx) – IHC DevelopmentRedmond, WA$90,000–$140,000 / yearThe 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. 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.
Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx) SystimmuneAssociate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx)Redmond, WA$150,000–$230,000 / yearThe successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining sufficiently hands-on to provide technical oversight and mentorship when needed. We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline.