Principal Scientist, Biomarker Bioanalytical Sciences
Core
Lead bioanalytical strategies and assay development for discovery, translational, and clinical-stage drug programs, ensuring data quality for regulatory submissions.
Role type
Principal Scientist, Bioanalytical Lead (IC)
Builds
Bioanalytical and biomarker data packages supporting IND, CTA, BLA, and other regulatory filings
Domain
Biotechnology / Drug Development / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biomarker and protein-based assay development, analytical validation in regulated environments, CRO oversight, ligand-binding and cell-based assay technologies, regulatory submission support, data interpretation, scientific writing
Preferred skills
clinical biomarker program experience, global regulatory submission authoring, scientific publication record
Technologies
ligand-binding platforms, cell-based assay platforms
Responsibilities
Develop and execute fit-for-purpose bioanalytical approaches (PK, ADA, TE, PD, Disease); Lead assay development, validation, and sample analysis plans; Provide scientific oversight of CROs and external laboratories; Review protocols, validation reports, and data packages for quality and compliance; Investigate assay issues and provide corrective actions; Interpret data and communicate findings to stakeholders; Contribute content for regulatory submissions; Support audits and inspections.
Seniority
Principal, hands-on IC with strategic oversight
