Your new company
An exciting growing organisation supporting the next generation of Oncology products.
Your new role
The CMC Technical Scientist position will be responsible for generating CMC documentation and providing cross-functional support with Regulatory affairs to prepare submission documents for regulatory bodies such as USFDA, EMA and Australian TGA.
The CMC Technical Scientist will interface between manufacturing vendors to generate CMC documentation and support Operations projects to ensure those activities meet regulatory guidelines and product development requirements.
What you'll need to succeed
* Tertiary Qualified in Chemistry or equivalent.
* Extensive experience working in a CMC-type position in Pharma
* Direct experience with peptide manufacturing is preferable.
* Working knowledge of cGMP, GCP, GLP, PIC/s and speciality regulatory guidelines
* Excellent oral and written communication skills
What you'll get in return
This company offers a flexible working environment with an opportunity to work anywhere in Australia with the occasional travel. The role has a competitive salary package and benefits with an opportunity to grow and develop in a company that continues to go from strength to strength in the Australian market.
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