The Senior Scientist leads the design, development, and lifecycle management of binding, enzymatic, and cell-based assays for biologics and advanced therapies
Job Summary
The Senior Scientist leads the design, development, and lifecycle management of binding, enzymatic, and cell-based assays for biologics and advanced therapies.
This role ensures methods are fit-for-purpose and phase-appropriate while providing scientific oversight for troubleshooting and OOS investigations.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative plasma fractionation, recombinant protein, and cell and gene therapy technologies.
Matching Summary
The Senior Scientist leads the design, development, and lifecycle management of binding, enzymatic, and cell-based assays for biologics and advanced therapies.
Skills & Requirements
Must-have
PhD in Biochemistry or related field
Binding and cell-based assay development
ICH Q2(R2) and ICH Q14 regulatory knowledge
Potency assay and MoA expertise
Analytical Target Profile authoring
Nice-to-have
Mentoring junior scientists
Cross-functional CMC strategy influence
Automation and digital data capture experience
Continuous improvement mindset
Regulatory submission support
Key Requirements
PhD in Biochemistry, Molecular Biology, Biotechnology, Immunology
Industry experience with biologics assay development
Proven track record supporting regulatory submissions