Role Description

This full-time, on-site Stability Chemist role is based in the Greater Melbourne Area and focuses on supporting pharmaceutical product development and quality. The Stability Chemist will design and execute stability studies for drug substances and drug products, including sample preparation, storage, and testing according to approved protocols and regulatory guidelines. Day-to-day activities include performing analytical testing, interpreting data, preparing reports, and maintaining accurate documentation in compliance with GMP and company procedures. The role also involves investigating out-of-specification or atypical results, collaborating with Quality Control, R&D;, and manufacturing teams, and contributing to method validation and continuous improvement initiatives. The Stability Chemist will help ensure products remain safe, effective, and compliant throughout their shelf life while supporting audits and regulatory submissions as needed.

Qualifications

- Robust laboratory skills, including safe handling of chemicals, preparation of solutions, and use of standard lab equipment.
- Proficiency in analytical skills, such as operating and troubleshooting instruments (e.g., HPLC, GC,



UV-Vis) and interpreting quantitative data.
- Experience in quality control, including GMP documentation practices, adherence to SOPs, and participation in investigations and CAPA processes.
- Background in research and development (R&D;) and research, with ability to design experiments, evaluate results, and optimize methodologies.
- Bachelor’s degree or higher in Chemistry, Pharmaceutical Science, or a related scientific discipline.
- Knowledge of stability guidelines and regulatory frameworks (e.g., ICH, TGA, FDA) relevant to pharmaceutical products.
- Strong attention to detail, organizational skills, and ability to manage multiple studies and timelines simultaneously.
- Effective written and verbal communication skills, with ability to prepare clear reports and collaborate in cross-functional teams.
- Comfort working in a GMP-regulated environment and participating in internal and external audits.
- Previous experience in pharmaceutical stability testing, QC, or analytical development is highly beneficial.

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📌 Stability Chemist for pharmaceutical industry (Melbourne)
🏢 Biological Therapies
📍 Melbourne