Entity: CSL Behring
Job Category: Research Development & Sciences
Job Family: Discovery & Product Development
Job Type: Full Time
Location: Melbourne, Victoria, Australia
Employer Reference: R-286003
The Role
CSL is a global biotechnology leader driven by a promise to save lives and protect the health of people around the world. As we continue to advance our immunoglobulin (Ig) and specialty product portfolio and are seeking an experienced Senior Scientist Drug Product and Stability, to provide scientific leadership across formulation, drug product process development and stability activities in CSL's Ig and Inframarginal product portfolio.
You will apply deep knowledge of biologics development, formulation science and stability to support product progression through the lifecycle, regulatory submissions, technology transfers and manufacturing excellence. You will champion Quality by Design (QbD) principles, scientific innovation and continuous improvement initiatives and collaborate with multidisciplinary teams locally and globally to deliver innovative solutions.
Your responsibilities
Part of a newly created team and based at CSL Melbourne, you will:
Define formulation, drug product process and stability development strategies aligned with portfolio and business objectives.
Act as a technical subject matter expert in biologics development, applying analytical and mechanistic understanding to support robust scientific decision-making.
Design, execute and interpret formulation, stability, container closure compatibility, in-use and robustness studies.
Generate scientific and CMC insights that support development milestones, regulatory submissions and lifecycle management activities.
Apply Quality by Design (QbD) principles and statistical experimental design methodologies to product and process development challenges.
Lead and support ICH-compliant GMP stability programs, including protocol development, study management, data trending, investigations and technical reporting.
Support internal and external technology transfers, including container closure selection, process risk assessments and Annex 1 compliance considerations.
Build and maintain deep scientific understanding of formulations, delivery devices and container closure systems to support commercial supply and future product improvements.
Drive innovation through the implementation of new technologies, automation, digitalisation and AI-enabled scientific approaches.
Collaborate effectively with partners across Analytical Development, Quality, Regulatory Affairs, Clinical Development, Device Development, Manufacturing Science & Technology, and external organisations.
Provide technical leadership, coaching and mentorship while effectively communicating scientific recommendations, project updates and critical risks to senior stakeholders.
Ensure laboratory, facility and equipment compliance with applicable quality and GMP/GSP requirements.
Your qualifications and experience
To be successful in this role you will bring:
A tertiary qualification in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, Chemical Engineering or a related discipline, which may be supported by a PhD or equivalent industry experience.
3+ years of experience in formulation development, stability and/or drug product process development within a regulated biopharmaceutical industry environment.
Strong technical leadership capability with a proven ability to define scientific direction and prioritise critical deliverables.
Experience working effectively within cross-functional global organisations.
Excellent written and verbal communication skills, including the ability to translate complex ideas.
Scientific curiosity and a passion for solving complex challenges in biologics development.
A growth mindset, strong learning agility and a collaborative approach to teamwork and scientific problem-solving within a research environment.
Apply Now if you want to help shape the next generation of therapies for patients worldwide!
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/.
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
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.
