Senior Scientist, Bioanalytical Compliance
CSL · Victoria
The Opportunity
At CSL, we are driven by our promise to save lives and protect the health of people around the world. We are seeking a highly motivated and scientifically accomplished Senior Scientist, Bioanalytical Compliance to join our Clinical Bioanalytics, Immunogenicity and Biomarkers team.
This is a unique opportunity to combine deep scientific expertise with regulatory compliance leadership, supporting bioanalytical activities across the full drug development lifecycle. You will play a critical role in ensuring our accredited laboratory facility meets global regulatory standards while contributing to innovative non-clinical and clinical development programs that advance life-changing therapies.
Your Responsibilities
Reporting to the Director, Bioanalysis, Immunogenicity and Biomarkers, you will provide scientific leadership and compliance expertise across Bioanalysis and Biomarker activities. Specifically, you will:
- Lead and support compliance activities within our accredited bioanalytical laboratory, ensuring alignment with OECD GLP, ISO 17025, GCP and applicable regulatory requirements.
- Support laboratory accreditation, audits, inspections and quality management activities, including CAPAs, deviations, investigations and continuous improvement initiatives.
- Provide scientific and compliance expertise for bioanalytical, biomarker and immunogenicity programs from preclinical research through clinical development.
- Partner with cross-functional teams to deliver project milestones, manage priorities, identify risks and ensure high-quality scientific outcomes.
- Contribute to assay development, validation strategies, experimental design, data analysis and scientific reporting while maintaining strong data integrity standards to ensure bioanalytical compliance.
- Build effective relationships with internal stakeholders, external partners, vendors and regulatory bodies to support program delivery.
- Promote innovation by identifying and applying emerging technologies, automation, digital solutions and AI-enabled approaches within regulated laboratory environments.
- Represent CSL within the broader scientific community through engagement with industry forums, conferences and collaborative networks.
About You
You are an experienced scientist who brings:
- Postgraduate qualification (preferably MSc or PhD) in Immunology, Biomedical Sciences, Life Sciences or a related discipline.
- Minimum 3 years' relevant industry experience or equivalent academic research experience.
- Demonstrated experience supporting bioanalytical, biomarker or immunogenicity programs within a regulated environment.
- Strong track record of scientific achievement and problem solving.
- Experience working in cross-functional and global matrix teams.
- Working knowledge of OECD GLP, ISO 17025, GCP and relevant FDA/EMA regulatory guidelines.
- Experience with laboratory quality systems, audits, inspections and accreditation requirements.
- Understanding of bioanalytical assay development, validation and clinical sample analysis.
- Knowledge of regulated data management and data integrity principles.
- Excellent written and verbal communication skills.
- Strong stakeholder engagement and influencing capability.
- Effective project planning and organisational skills.
- Ability to navigate complexity and balance compliance requirements with scientific innovation.
Apply now and help deliver innovative therapies that improve the lives of patients around the world.
About CSL Behring
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/.
Our Benefits
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.