Principal Scientist - Bioanalytical Quality Scientist
Core
Lead biomarker assay quality oversight for clinical development, ensuring scientific rigor and fit-for-purpose validation across multiple platforms.
Role type
Senior Principal Scientist (Bioanalytical Quality Lead)
Builds
Validated biomarker assays supporting clinical endpoints and development decisions
Domain
Biotechnology / Clinical Development / Biomarker Assay Development
Required skills
Advanced degree (Ph.D./M.D.), 3+ years in clinical assay development/validation, broad analytical-validation experience, molecular testing expertise (DNA/RNA/histochemistry), regulatory knowledge (CLIA/CAP), fit-for-purpose validation principles
Preferred skills
Experience with next-generation sequencing, immunohistochemistry, AI-enabled pathology, ligand-binding assays, proteomics, LC-MS, metabolomics, flow cytometry, qPCR/qRT-PCR
Technologies
NGS, IHC, AI pathology, LBA, Proteomics, LC-MS, Metabolomics, Flow Cytometry, qPCR
Responsibilities
Provide independent scientific and quality oversight for assay development and validation; Review and approve scopes of work, validation plans, and final reports; Define validation strategies and design pilot studies to control preanalytical variables; Partner with internal teams and external labs to ensure proper assay implementation; Conduct technical assessments and site visits; Influence standardization of specimen handling and quality practices; Collaborate to translate research assays into validated clinical methods
Seniority
Senior, hands-on IC