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.
Position Description Summary:
The Principal Toxicologist will prepare Toxicological Risk Assessments (TRAs) across diverse projects supporting R&D, CMC, and Quality, ensuring alignment with global regulatory standards and may author nonclinical submission documents. A key responsibility is the rapid evaluation of unexpected manufacturing, release, or stability deviations to support decisions on patient safety, product quality, and business continuity.
This global role requires strong cross‑functional collaboration and engagement with external experts, including participation in worldwide project teams and assessment meetings.
Main Responsibilities:
Organize, prepare, and peer-review toxicological risk assessments supporting R&D projects and Quality initiatives.
Apply advanced toxicological principles—including literature evaluation, SAR/read‑across methodologies, and health‑based exposure limit setting (e.g., PDE/ADE, AI, OEL, TE, TTC).
Compile comprehensive Toxicological Risk Assessments for impurities, extractables and leachables (E&L), excipients, and other product components, aligned with ICH, EMA, and FDA guidelines.
Conduct rapid assessments of unexpected deviations during manufacture, release, or stability testing of starting materials, intermediates, or final products.
Evaluate potential impact on patient safety, product efficacy, and regulatory compliance within stringent timelines.
Collaborate with Global Clinical Safety & Pharmacovigilance when medical interpretation is required.
Support the review of Product Technical Complaints, based on product trends and complaint categories.
Serve as the Toxicology representative on interdisciplinary global project teams across therapeutic areas.
Foster strong collaboration with internal stakeholders and build a global network of external experts in toxicology and risk assessment.
Stay current with evolving toxicology guidelines, scientific advancements, and regulatory trends.
Qualifications and Experience Requirements:
Advanced degree (PhD, DVM, PharmD, MSc) in Toxicology, Pharmacology, Biomedical Sciences or a related discipline. Board Certification (ERT or DABT) or equivalent is a plus.
5-8 years of experience in pharmaceutical or biotech industry.
Proven track record in nonclinical safety assessment and regulatory submissions.
Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
Excellent communication, leadership, and cross-functional collaboration skills.
Experience with CSL’s disease therapeutic areas.
Experience across multiple therapeutic areas and modalities is highly desirable.
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.
