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, recent 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 flexible 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 ****

📌 Scientist, Drug Product Formulation Development (Victoria)
🏢 Csl Behring
📍 Victoria