Analytical Development Chemist

About Us

IDT Limited Australia has a proud heritage of nearly 50 years borne out of the Victorian College of Pharmacy in Parkville, Melbourne, Australia as a true biotechnology organisation helping develop and scale up new and emerging medicines and technologies many of which are part of the mainstay in Australian healthcare today.

Today, IDT continues to partner with a broad range of clients around the globe through the Americas, Europe and Asia Pacific focused on development and scale up and transfer into clinical phase and commercial manufacture and shipping around the world. IDT is TGA, FDA and EU accredited and focused on building on its legacy into these new emerging areas of science to set a foundation for the next 50 years in IDT’s legacy and role in Australian and global healthcare and service needs

The role

We are building on our team of technical experts and seeking an experienced Analytical Development Chemist to join our existing highly capable, motivated, and tight-knit team.

This role involves:

• Developing and validating analytical test methods related to activities for R&D and commercial projects.
• Developing specifications for key raw materials and finished products for development and commercial projects.
• Providing method development and validation expertise, as required. 
• Providing analytical support for process validation. 
• Implementing process improvement disciplines for the laboratory processes in order to maximise efficiency and ensure compliance. 
• Supporting regulatory affairs with submission and answering regulatory questions. 
• Supporting new product development projects and new production introduction and technology transfers. 
• Effective reporting and scientific and technical writing according to GLP/GMP and IDT’s quality systems. 

Required Background and Experience: 

• Post graduate scientific qualifications in organic or synthetic chemistry up to doctorate is preferred. . 
• At least 5 years’ experience in the pharmaceutical industry and working in accordance with FDA and TGA regulations. 
• Experience in method development and validation. 
• Excellent knowledge of analytical techniques including GC, HPLC, UPLC and wet chemistry. 
• Extensive capability and demonstrated experience in development, validation, tech transfer and product life cycle is preferred. 
• Strong understanding of chemistry laboratory processes, instrumentation and analytical techniques.
• Strong written communication and report writing skills and protocols. 
• Well organised, with proven project management capability is preferred. 
• Knowledge and ability to navigate ICH guidelines and pharmacopoeias.
• Excellent organisational skills, flexibility, ability to work independently and in a team.