The MS&T (Manufacturing,Science & Technology) Analytical Specialist carries out analytical testing of drug substances and intermediates in support of process development / characterization / optimization studies, as well as forensic testing in support for commercial drug substance manufacturing and material release decisions.
The trainee will be able to:
- develop a strong quality mindset with regard to data integrity, Good Documentation Practice, Good Manufacturing Practice, and Development Quality Practice
- perform analytical testing independently for selected methods (eg. HPLC and ELISA based methods), specifically setting up HPLC systems for the relevant assays, prepare test samples for analysis, process and analyse the test results and perform simple troubleshooting for aberrant runs and abnormal results
- support forensic testing and develop solid practical experience in managing forensic test specimen receipt, preparation, perform standard forensic testing (microscopy, solubility, FT-IR), support to establish an in-house FT-IR reference material and spectral library
- manage (author and/or document management in relevant platforms) MS&T Documents within the framework of applicable quality standards
- support MS&T equipment qualification and/or maintenance /calibration in compliance to applicable quality standards
- support MS&T Process Sciences Laboratory inventory management ranging from the receipt of delivery to stock keeping including the business process for VSR+ platform
- GMP and DQP quality management systems and related corporate systems and processes
- Laboratory inventory management including virtual stock management system
- Analytical testing for anti-body based drug substance and intermediates
- Forensic testing in a cell culture baed biomanuafacturing facility
Duration of training
This position is for both recent graduates and mid career individuals. Graduates interested in this position should possess a Degree qualification. Mid career individuals from any qualitication level may apply.