QC Validation Scientist

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.

About CSL Behring

Qualifications

• 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
• HPLC
• Ion Exchange Chromatography (IEX)
• CE-SDS
• ELISA
• Potency assays
• UV-Visible Spectroscopy
• Protein concentration assays
• Endotoxin testing