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 adaptable 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 ****
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📌 Scientist, Drug Product Formulation Development (Melbourne)
🏢 CSL
📍 Melbourne