Scientist, Drug Product Formulation Development

Csl Limited; City of Melbourne; On-site; AUD 90,000 - 140,000; Full time

Job summary

CSL Behring, based in Melbourne, Australia, is seeking a Scientist in Drug Product Formulation Development to design, execute and interpret formulation development, drug product and stability studies across its recombinant portfolio.

You will apply QbD and advanced technologies to deliver robust, compliant solutions supporting pre-clinical, clinical, regulatory submissions and commercial manufacturing.

Qualifications

• Experience with physicochemical assays and formulation development in a pharmaceutical environment.
• Ability to design and execute scientific experiments and studies.
• Proficient data acquisition, collation, analysis and reporting of results.
• Strong written and verbal communication skills for peers and senior leadership.

Responsibilities

• Conduct formulation development studies for development and early clinical trials.
• Ensure accurate data acquisition, analyses and record-keeping.
• Document and report studies in line with quality and regulatory guidelines.
• Maintain safety standards per CSL policies and regulations.
• Provide expert scientific skills at the bench and workstation.
• Develop facilities, labs and equipment to required standards.
• Collaborate with CSL teams and global sites.
• Manage procurement, storage and maintenance of materials and equipment.
• Lead change controls, investigations and validation activities.
• Identify opportunities for process improvements and implement.

Skills

Physicochemical assays

Formulation development

Cross-functional collaboration

Data analysis

Education

Bachelor's or higher in Pharmaceutical Sciences or related field

Job description

Scientist, Drug Product Formulation Development

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 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 2026

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.