Senior Scientist –Bioassays (m/f/x) — CSL Behring

Role overview

Title: Senior Scientist –Bioassays Function: Method Development, Tech Ops Reports to: Associate Director, Method Development Role Purpose: The Senior Scientist responsible for the design, development, qualification, and lifecycle management of binding, enzymatic, and cell‑based assays supporting biologics and advanced therapies across discovery, development, and commercial stages.

This role provides deep technical expertise for complex bioassays, ensuring methods are fit-for-purpose, phase-appropriate and robust, while mentoring scientists and influencing cross‑functional CMC strategy.

Key Responsibilities: Scientific & Technical Leadership

• Lead the development and optimization of binding assays (e.g., ELISA, SPR/BLI), enzymatic assays, and cell‑based bioassays for potency, MoA, and characterization.

• Define assay strategy aligned to MoA, CQAs, and clinical phase, including selection of reference materials, controls, and acceptance criteria.

• Resolve complex assay challenges, including variability, matrix effects, specificity, drift, and biological relevance.

• Drive assay robustness, mechanistic understanding, and biological relevance, particularly for potency and functional assays.

Method Validation & Lifecycle Management

• Author and approve Analytical Target Profiles (ATP), Method Development reports and Pre-qualification reports in alignment with ICH Q2(R2), ICH Q14, USP, and EP expectations.

• Ensure methods are phase‑appropriate and support comparability, tech transfer, and post‑approval changes.

• Provide scientific oversight for method troubleshooting, OOS/OOT investigations Technology & Innovation:
• Evaluate and implement new assay technologies and platforms (e.g., automation, digital data capture, novel readouts).

• Champion continuous improvement in assay throughput, reproducibility, and data integrity.