Lead QC Validation Scientist - Biologics

Csl Behring; Melbourne; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive remuneration and benefits

Job summary

CSL Behring is seeking an experienced QC Validation Analytical Scientist to join the Quality Control Validation team at Broadmeadows. The role focuses on validation, transfer, and lifecycle management of analytical methods for biologics and protein-based products used in release and stability programs.

The successful candidate will lead method validation activities, ensure alignment with ICH, USP, Ph. Eur., and GMP standards, and collaborate across QC, Process Development, QA, Manufacturing, and

Qualifications

• Bachelor’s degree or Master’s in Biochemistry, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences, or 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 GMP/pharma/biologics environments.
• Experience with protein-based products (recombinant proteins, mAbs, plasma-derived therapies, vaccines) is desirable.
• Strong understanding of analytical method lifecycle management and regulatory requirements.
• Experience writing and reviewing validation protocols and technical reports.
• Troubleshooting and investigation skills.
• Excellent communication and stakeholder management capabilities.
• Experience with LIMS, electronic quality systems, and controlled documentation systems is advantageous.
• Commitment to GMP compliance, quality, and data integrity.

Responsibilities

• Lead design, execution, and reporting of method validation, verification, qualification, and transfer studies.
• Develop validation strategies aligned with ICH, USP, Ph. Eur., and GMP requirements.
• Provide technical leadership and troubleshooting for analytical methods in protein therapeutics testing.
• Statistical assessment of validation data and evaluation of method performance (accuracy, precision, linearity, robustness).
• Author and review validation protocols, reports, risk assessments, changes, deviations, CAPAs, and technical docs.
• Collaborate with cross-functional stakeholders to support new product introduction and method transfer.
• Support internal and external audits and regulatory inspections with technical expertise and documentation.

Skills

Analytical method validation

cGMP experience

Problem solving

Communication skills

Stakeholder management

Quality documentation

Cross-functional collaboration

Audits/regulatory

LIMS experience

Data integrity

Education

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

Tools

LIMS

Electronic quality systems

Controlled documentation systems

Job description

CSL Behring is seeking an experienced QC Validation Analytical Scientist to join the Quality Control Validation team at Broadmeadows. The role focuses on validation, transfer, and lifecycle management of analytical methods for biologics and protein-based products used in release and stability programs.

The successful candidate will lead method validation activities, ensure alignment with ICH, USP, Ph. Eur., and GMP standards, and collaborate across QC, Process Development, QA, Manufacturing, and