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Senior Chemist
2 months ago
This is a pivotal position within the radiopharmaceuticals manufacturing division, serving as a bridge between the process improvement team and the chemistry management team. The successful candidate will lead investigations, manage projects, and ensure deliverables are met, with a focus on continuous improvement (CI) projects beyond routine analytical QC testing.
Key Responsibilities- Product Specialist / SME: Manage all continuous improvement projects related to the product manufactured.
- Method Development and Research: Perform higher-level method development, research investigations, analysis of raw materials, intermediates, and finished goods using analytical equipment.
- Collaboration and Communication: Collaborate across CI, manufacturing teams from A-Z, including release of raw materials, intermediates, and finished goods.
- Project Leadership: Lead and investigate projects into products, including CAPAs, deviations, and OOS.
- Quality and Technical Documentation: Maintain documentation, including procedures, work instructions, specifications, quality plans, and other quality and technical documents.
- Regulatory Compliance: Provide technical information for submissions to regulating authorities and customers.
- Troubleshooting and Audits: Perform technical troubleshooting for a range of instrumentation and test methodology, and participate in regulatory audits (TGA, FDA, and ARPANSA).
- Education: Degree in Science with a Chemistry or related major.
- Citizenship: Australian Citizenship required.
- Experience: Knowledge of analytical instrumentation and analytical techniques, such as ICP-MS/OES, HPLC. Experience working within a highly regulated industry, GMP environment, and pharmaceutical QC experience highly regarded.
- Skills: Proven project management experience, ability to collaborate and communicate effectively, strong time management skills, and commitment to meeting tight deadlines.
- Salary and Benefits: Generous salary on offer, including 15.4% Super and 33% shift loading.
- Leave and RDO: Additional 10 days leave, 6 weeks of annual leave, and 1 x RDO/month.
- Work Schedule: Rotating shift, 6am-2pm / 9am-5pm, and 1 Sunday/month.
