Senior Principal Scientist
Core
Develop analytical strategies and methods for cellular drug products (cell and gene therapy) to support product release, characterization, and regulatory submissions.
Role type
Senior Principal Scientist (Cellular Therapy CMC)
Builds
Cellular drug products and analytical methods for clinical programs
Domain
Biopharmaceuticals / Cell and Gene Therapy / Chemical Manufacturing and Controls (CMC)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC analytical strategy development, gene editing (CRISPR-Cas9), large dataset analysis for clinical products, regulatory filing drafting (IND/BLA), analytical method development and transfer
Technologies
CRISPR-Cas9, analytical instrumentation for cell therapy
Responsibilities
Develop CMC analytical strategies for cell and gene therapy products; Utilize gene editing technologies to create engineered T-cells; Analyze large datasets for multiple clinical cellular products; Draft technical regulatory filings including IND amendments and BLAs; Develop and transfer cellular or biologics analytical methods suitable for QC or characterization; Justify drug product specifications for clinical programs
Seniority
Senior, hands-on IC
