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.
- 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 cell‑based assays for biologics.
- Demonstrated expertise in potency assay development and MoA‑linked 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 cross‑functional influence.
About CSL Behring
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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
