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Investigator I (Toxicology)

CSL Behring

This is a Contract position in Cambridge, MA posted October 11, 2020.

About CSL With operations in 35 nations and 22,000 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 the second largest influenza vaccine company 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 Job Description This position provides toxicological expert support and guidance on nonclinical safety assessment, ensures regulatory compliance in toxicology study conduct to support vaccine discovery and development.

1.

Develop toxicology strategies and provide toxicological expert support Collaborate with multi-functional teams to provide toxicological support and guidance to research and development programs.

Provide support to multi-functional research project teams to develop optimal strategies to address specific safety issues.

2.

Plan, monitor, analyze 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 synthesis, formulation and delivery for use in toxicology studies.

Monitor toxicology studies, ensure quality and timely execution in line with appropriate quality and regulatory compliance (WHO, FDA, ICH and GLP), proactively manage interactions with CROs and facilitate timely issue resolutions.

3.

Documentation and presentation of toxicology study results Summarize and present data at cross-functional meetings or to key internal and external audiences.

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.

4.

Manage and prepare toxicological risk assessments to support manufacturing Evaluate data from extractable and leachable studies.

Support manufacturing as required for changes in specifications, investigations into deviations and out-of-specification results.

5.

And other job duties that may be assigned from time to time Support other functions and other divisions when needed.

Job Summary : This position provides toxicological expert support and guidance on nonclinical safety assessment, ensures regulatory compliance in toxicology study conduct to support vaccine discovery and development.

Major Accountabilities Develop toxicology strategies and provide toxicological expert support Collaborate with multi-functional teams to provide toxicological support and guidance to research and development programs.

Provide support to multi-functional research project teams to develop optimal strategies to address specific safety issues.

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 synthesis, formulation and delivery for use in toxicology studies.

Monitor toxicology studies, ensure quality and timely execution in line with appropriate quality and regulatory compliance (WHO, FDA, ICH and GLP), proactively manage interactions with CROs and facilitate timely issue resolutions.

Documentation and presentation of toxicology study results Summarize and present data at cross-functional meetings or to key internal and external audiences.

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 Evaluate data from extractable and leachable studies.

Support manufacturing as required for changes in specifications, investigations into deviations and out-of-specification results.

Minimum Requirements: MS or PhD in Toxicology or related pharmaceutical sciences.

MS with 5 years or PhD with 2 years of pharmaceutical/biotech/CRO experience in toxicology.

Experience in development of vaccines and immunotoxicology is desired.

Prior experience in working with CROs; design, execution and reporting of GLP toxicology studies.

Ability to travel to manage CRO/vendor collaborations (15%).

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 E&L toxicology assessments is desired.

Demonstration of intellectual and scientific curiosity, a high level of engagement and personal initiative.