Senior Scientist –Bioassays (mfx)

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 cellbased 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 crossfunctional CMC strategy.

Key Responsibilities:

Scientific & Technical Leadership:

• Lead the development and optimization of binding assays (e.g. ELISA SPR/BLI) enzymatic assays and cellbased 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 phaseappropriate and support comparability tech transfer and postapproval 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.
• Partner with automation data and IT teams to modernize bioassay workflows.

Required Qualifications & Experience:

• PhD in Biochemistry Molecular Biology Biotechnology Immunology or related discipline (or equivalent experience).
• Industry experience developing binding enzymatic and/or cellbased assays for biologics.
• Demonstrated expertise in potency assay development and MoAlinked bioassays.
• Strong working knowledge of ICH Q2(R2) ICH Q14 and regulatory expectations for bioassays.
• Proven experience supporting regulatory submissions and inspections.
• Track record of scientific leadership mentoring and crossfunctional influence.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

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