Qc Validation Scientist

Csl Behring; Melbourne; Sur place; AUD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Competitive remuneration and benefits

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical method validation

cGMP experience

Problem solving

Communication skills

Stakeholder management

Quality documentation

Cross-functional collaboration

Audits/regulatory

LIMS experience

Data integrity

Formation

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

Outils

LIMS

Electronic quality systems

Controlled documentation systems

Description du poste

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
• UV-Visible Spectroscopy
• Protein concentration 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.