As a Scientist, Drug Product Formulation Development, you will design, execute and interpret formulation development, drug product and stability studies across CSL's recombinant product portfolio. Working collaboratively with cross-functional teams, you will generate critical scientific and CMC insights that support pre-clinical and clinical development, regulatory submissions, technology transfer and commercial manufacturing.
Applying
Quality by Design (QbD) and science-based approaches, you will deliver robust, compliant solutions while driving continuous improvement through innovative technologies, new methodologies and operational excellence.
Key Responsibilities
- Conduct experimental studies and activities involving the formulation, aseptic processing, dispensing/sampling, testing, storage, use and stability trial management of development and scaled-up products and processes for pre-clinical and early clinical trials
- Accurate and reliable data acquisition, analyses and record keeping to support new product and process development
- Document and report experimental studies and activities for all work in accordance with quality and regulatory guidelines and policies
- Ensure safety standards are maintained to local and federal laws, as well as CSL policies and directives
- Deliver expert scientific skills at the bench and workstation
- Develop and maintain facilities, laboratories and equipment to required quality standards
- Work and collaborate closely with scientists and colleagues across different CSL teams and global sites
- Identify and manage the procurement, storage and maintenance of pharmaceutically active materials, chemicals and equipment
- Leading role in change controls, process investigations, risk assessments and validation activities
- Identify opportunities for improvement and bring these to the team for assessment and/or implementation
- Explains complex or technical information clearly and accurately to others
- Regularly participate in technical, operational and organisational discussions and presentations at team meetings
- Be versatile and adaptable to changes in project and workplace priorities
Qualifications, Skills & Experience
- Bachelor or postgraduate qualification in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, Chemical Engineering or related scientific discipline
- Minimum 3 years experience with training in relevant technical discipline
- Demonstrated experience with physicochemical assays and/or formulation and drug product development activities in a pharmaceutical environment
- Ability to design and complete scientific experiments and studies
- Proficient data acquisition, collation, analysis and reporting skills
- Ability to contribute and work in a cross-functional, multi-disciplinary global team environment, and independently when required
- Demonstrated verbal and written communication skills to peers and senior leadership
- Well established multi-tasking, problem solving and time management skills
Closing Date for Applications: 8th October 2026
📌 Scientist, Drug Product Formulation Development (Melbourne)
🏢 CSL
📍 Melbourne