Contract QC Validation Scientist - Biologics

CSL; Melbourne; In loco; AUD 85.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive remuneration

Broadmeadows site

Career development opportunities

Descrizione del lavoro

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,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical method validation

cGMP

Project management

Stakeholder communication

Troubleshooting

Formazione

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

Strumenti

LIMS

Electronic quality systems

Descrizione del lavoro

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,