Senior Scientist, Regulatory Toxicology

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

The Senior toxicologist will prepare risk assessments (toxicological / pharmacological/ medical) supporting R&D, production and marketing in all therapeutic areas of CSL Behring, CSL Seqirus; CSL Vifor and CSL Plasma. This role will also be responsible for the assessment of impact of unexpected deviations during manufacture, release or stability testing of starting material, an intermediate or final product within a short turnaround time.

The Senior toxicologist will liaise closely with global cross-functional project teams and interact with external experts.

The Role:

• Prepare and review risk assessments supporting R&D projects and Quality, liaising closely with e.g., Project Toxicologists, CMC, Manufacturing Site Pharmacovigilance Responsible (MSPR)/Global Clinical Safety and Pharmacovigilance (GCSP)

• Set exposure limits: PDE/ADE, AI, OEL, TE, and TTC

• Perform toxicological assessments on leachables/extractables

• Assessment of prospective impact of unexpected deviations from 1.) specified or usual quality profile during manufacture or release testing of the starting material, an intermediate or final product on the safety and efficacy of the product in patients within its labeled use and 2.) usual stability profile of the product on safety, tolerability, and efficacy of the product on the market, where appropriate, together with Global Clinical Safety and Pharmacovigilance (GCSP).

• Use state-of-the-art assessment methods based e.g. on literature available in freely accessible databases, use Structure/Activity Relationships (SAR), read-across methodologies, etc.

• Perform review of Product Technical Complaints, as needed, according to product trends and types of complaints

• Serve as function's representative across R&D projects across therapeutic areas

• Actively establish and foster a high quality, global network with relevant experts internally and externally

Your Skills and Experience:

• University Degree in Life Sciences or closely related fields (e.g. PhD, MD, PharmD)

• Toxicology training (board certification preferred)

• 1-3 years of relevant experience as non-clinical toxicologist in a biotechnology, pharmaceutical or CRO setting

• Additional experience in biopharmaceutical development.

• In depth knowledge of relevant regulatory guidelines.

• Strong scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology

• Fluent in English (Proficient written, verbal and presentation skills)

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

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.

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. Learn more Inclusion and Belonging | CSL.