Investigator I (Toxicology)
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
This position provides toxicological expert support and guidance on nonclinical safety assessment of vaccine discovery and development. The individual will ensure regulatory compliance in toxicology studies and support timely submission of study results to regulatory authorities.Major Accountabilities:
Develop toxicology strategies and provide toxicological expert support
- Serve as a toxicology representative in multi-functional project teams to independently develop robust toxicology plan for assigned programs.
- Provide support to multi-functional research project teams to develop effective strategy to address specific safety concerns.
Plan, monitor, analyse and report nonclinical toxicology studies conducted in collaboration with contract research organizations
- Oversee toxicology study conduct at external Contract Research Organizations (CROs), initiate appropriate processes for contract implementation, study protocol development and timeline optimization. Ensure test material availability for toxicology studies.
- Monitor toxicology studies, ensure quality and timely execution in line with regulatory submission dates.
- Critically review study reports and proactively interact with CROs to understand toxicological findings.
Documentation and presentation of toxicology study results
- Summarize and present data at cross-functional meetings internally and at external conferences.
- Prepare or review non-clinical sections of regulatory documents, including pre-IND or scientific advice briefing documents, IND or CTA, IBs, DSURs, PSURs and other documents; ensures their compliance with various regulatory authorities/guidelines.
Manage and prepare toxicological risk assessments to support manufacturing
- Conduct risk assessment in manufacturing as required for changes in specifications, investigations into deviations and out-of-specification results.
- Evaluate data from extractable and leachable studies and write up risk assessment reports.
And other job duties that may be assigned from time to time
- Support toxicology SOP drafting, internal/external auditing
- Organize toxicology sharepoint, study tracking, and other departmental initiatives
- PhD in Toxicology or related pharmaceutical sciences. DABT is a plus.
- PhD with 2+ year pharmaceutical/biotech/CRO experience in toxicology preferred
- Prior experience in working with CROs; design, execution and reporting of GLP toxicology studies.
- Familiarity with WHO/FDA/ICH guidelines and GLP regulations for the conduct of toxicology studies to support regulatory filings.
- Experience in regulatory submissions, including IND/CTA and BLA/NDA is desired.
- Experience in development of vaccines and immunology.
- Experience in manufacturing risk assessment and E&L assessment are desired.