QC Validation Scientist

CSL; Melbourne; On-site; AUD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive remuneration

Broadmeadows site

Career development opportunities

Job summary

CSL Behring is seeking an experienced QC Validation Analytical Scientist to join their Quality Control Validation team at the Broadmeadows site in Melbourne. The role focuses on validation, verification, transfer, and lifecycle management of analytical methods for product release, stability, and process monitoring.

You will work with QC Operations, Process Development, QA, Manufacturing, and Regulatory Affairs to ensure methods are robust and compliant throughout the product lifecycle,

Qualifications

• Bachelor’s degree or Master’s in Biochemistry, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 3 years’ experience in a cGMP Quality Control laboratory or equivalent postgraduate research experience.
• Demonstrated experience in analytical method validation within GMP pharma/biotech/biologics/vaccine manufacturing.

Responsibilities

• Lead design, execution, and reporting of analytical method validation, verification, qualification, and transfer studies.
• Develop validation strategies aligned with ICH, USP, Ph. Eur., and GMP requirements.
• Provide technical leadership and troubleshooting support for analytical methods for protein therapeutics and biologics.
• Perform statistical assessment of validation data and evaluate method performance characteristics (accuracy, precision, specificity, linearity, robustness, range).
• Author and review validation protocols, reports, risk assessments, change controls, deviations, CAPAs, and technical documents.
• Collaborate with cross-functional stakeholders to support new product introduction, method transfer, and continuous improvement.
• Support internal and external audits and regulatory inspections with technical documentation.

Skills

Analytical method validation

cGMP

Project management

Stakeholder communication

Troubleshooting

Education

Bachelor’s or Master’s in Biochemistry/Analytical Chemistry/Pharmaceutical Sciences

Tools

LIMS

Electronic quality systems

Job description

An exciting opportunity exists for an experienced QC Validation Analytical Scientist to join our Quality Control Validation team supporting biologics and protein-based products. In this role, you will be responsible for the validation, verification, transfer, and lifecycle management of analytical methods used to support product release, stability studies, and process monitoring.

You will act as a technical subject matter expert, working closely with QC Operations, Process Development, Quality Assurance, Manufacturing, and Regulatory Affairs to ensure analytical methods are robust, compliant, and fit for purpose throughout the product lifecycle.

This is a fixed term contract until February 2028 based at our Broadmeadows site

Key Responsibilities

• Lead the design, execution, and reporting of analytical method validation, verification, qualification, and transfer studies.
• Develop scientifically sound validation strategies aligned with ICH, USP, Ph. Eur., and GMP requirements.
• Provide technical leadership and troubleshooting support for analytical methods used in the testing of protein therapeutics and biological products.
• Perform statistical assessment of validation data and evaluate method performance characteristics including accuracy, precision, specificity, linearity, robustness, and range.
• Author and review validation protocols, reports, risk assessments, change controls, deviations, CAPAs, and technical documents.
• Collaborate with cross-functional stakeholders to support new product introduction, method transfer, and continuous improvement initiatives.
• Support internal and external audits and regulatory inspections by providing technical expertise and documentation.

About You

You are a scientifically driven professional with strong analytical and problem-solving skills. You enjoy investigating method performance issues, identifying root causes, and delivering practical solutions in a GMP-regulated environment.

Essential Qualifications and Experience

• Bachelor’s degree or Master’s in Biochemistry, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 3 years' experience in a cGMP Quality Control laboratory or equivalent postgraduate research experience.
• Demonstrated experience in analytical method validation within a GMP pharmaceutical, biotechnology, biologics, or vaccine manufacturing environment.
• Experience working with protein-based products such as recombinant proteins, monoclonal antibodies, plasma-derived therapies, or vaccines is highly desirable.
• Strong understanding of analytical method lifecycle management and regulatory requirements.
• Experience writing and reviewing validation protocols and technical reports.
• Proven troubleshooting and investigation skills.
• Excellent communication and stakeholder management capabilities.
• Experience with LIMS, electronic quality systems, and controlled documentation systems is advantageous.
• Strong scientific and technical capability.
• Ability to manage multiple priorities and projects simultaneously.
• Commitment to GMP compliance, quality, and data integrity.
• A collaborative approach and willingness to support team success.
• Passion for continuous improvement and innovation.

Technical Experience

Experience with several of the following techniques is highly desirable:

• HPLC
• Ion Exchange Chromatography (IEX)
• CE-SDS
• ELISA
• Potency assays
• Endotoxin testing

What We Offer

• Opportunity to contribute to the manufacture of life-saving biologic medicines.
• Exposure to complex analytical and validation projects.
• Collaborative and inclusive team environment.
• Professional development and career growth opportunities.
• Competitive remuneration and benefits.

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.