Our client is a reputable Pharmaceutical Company situated in the Inner suburbs of Melbourne. They have requested the assistance of Evolve Scientific Recruitment to source an Analytical Scientist for on a permanent basis.
About the role:
Reporting directly to the Analytical Services Manager, this role will require you to ensure work is achieved and delivered to a high standard.
Key responsibilities in the following areas:
- Perform QC release of drug substances, excipients, components and finished products.
- Supervise and perform stability testing of investigative/laboratory and clinical or regulatory batches.
- Maintain the stability schedule and co-ordinate stability testing.
- Write and review QC, stability and validation documentation including protocols, reports, methods and specifications to industrial, regulatory and quality standards.
- Develop and implement testing protocols in accordance with the relevant regulatory guidelines.
- Evaluate stability data generated and make predictions/trending as required.
- In consultation with Analytical Development Manager release data to external parties as required.
- Coordinate or perform activities in accordance to validation master plan including computer and instrument qualifications.
- Support manufacturing and analytical activities that may relate to other functions, including analytical development activities e.g. method development, validation, process validation and drug product characterisation studies.
- Communicate scientific results and concepts in a clear and concise manner verbally, in written reports and through presentations.
- Proficient in the use of software applications such as Excel, PowerPoint, and Word.
- Able to apply scientific rigour to the interpretation of data.
- Highly developed troubleshooting/problem solving ability.
- Work to high quality standards.
- Solid understanding of pharmaceutical development programs and GMP/GLP.
- Experience in the development and validation of stability indicating assays.
- BSc or equivalent degree with a sound understanding of the pharmaceutical industry stability requirements, including proficient use of HPLC and GC analytical techniques and other laboratory instrumentation.
- Excellent technical and managerial background and a thorough understanding of quality systems.
- Excellent organisational, proven people and time management skills, attention to detail and strong ability to multi-task
- Flexible “can do” attitude.
- Ability to deliver programs to timelines.
- Ability to demonstrate leadership and initiative whilst working autonomously or as part of a team.
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letterAND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Cathy or Linda on 9040 1630
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