Job Description
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 n
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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
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Accurate and reliable data acquisition, analyses and record keeping to support new product and process development
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Document and report experimental studies and activities for all work in accordance with quality and regulatory guidelines and policies
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Ensure safety standards are maintained to local and federal laws, as well as CSL policies and directives
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Deliver expert scientific skills at the bench and workstation
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Develop and maintain facilities, laboratories and equipment to required quality standards
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Work and collaborate closely with scientists and colleagues across different CSL teams and global sites
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Identify and manage the procurement, storage and maintenance of pharmaceutically active materials, chemicals and equipment
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Leading role in change controls, process investigations, risk assessments and validation activities
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Identify opportunities for improvement and bring these to the team for assessment and/or implementation
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Explains complex or technical information clearly and accurately to others
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Regularly participate in technical, operational and organisational discussions and presentations at team meetings
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Be flexible and adaptable to changes in project and workplace priorities
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Qualifications, Skills & Experience n
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Bachelor or postgraduate qualification in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, Chemical Engineering or related scientific discipline
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Minimum 3 years experience with training in relevant technical discipline
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Demonstrated experience with physicochemical assays and/or formulation and drug product development activities in a pharmaceutical workplace
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Ability to design and complete scientific experiments and studies
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Proficient data acquisition, collation, analysis and reporting skills
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Ability to contribute and work in a cross-functional, multi-disciplinary global team environment, and independently when required
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Demonstrated verbal and written communication skills to peers and senior leadership
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Well established multi-tasking, problem solving and time management skills
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Closing Date for Applications: 8th October ****
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📌 Scientist, Drug Product Formulation Development (Melbourne)
🏢 CSL
📍 Melbourne