GMP Analytical Scientist, Tech Ops (12-Month)

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

Job summary

CSL Behring in Melbourne seeks an experienced Scientist to join the GMP Analytical Testing team for a 12-month fixed-term period. You will plan and execute GMP analytical testing, support stability programs and assay qualification, and contribute to technology transfer with strong data integrity.

You will collaborate with Quality Assurance and project teams, manage laboratory activities with ownership, and maintain inspection-ready operations using LIMS, ELN, and instrument control software.

Qualifications

• Bachelor’s or postgraduate qualification in analytical biochemistry, chemistry, molecular and cellular biology, pharmaceutical sciences or a related discipline.
• 3+ years’ relevant laboratory experience in biotechnology, pharmaceutical or biopharmaceutical industries.
• Hands-on experience with protein biochemistry and/or bioanalytical techniques (HPLC, CE-SDS, icIEF, ELISA, UV-Vis).
• GMP or regulated laboratory experience with data integrity and compliant documentation.
• Experience using LIMS, ELN, instrument control software and MS Office.
• Strong organisational and stakeholder-management skills.

Responsibilities

• Perform GMP analytical testing to support batch release and stability programs.
• Execute and review analytical experiments using protein biochemistry and bioanalytical methods.
• Support stability studies including protocol development, scheduling, sample management and reporting.
• Contribute to quality system activities (deviations, CAPAs, investigations, change controls, risk assessments).
• Assist assay qualification and technology transfer activities with data analysis and reporting.
• Prepare GMP documentation and maintain data packages and technical reports.
• Collaborate with QA, project teams and external partners to achieve timelines.
• Maintain inspection-ready laboratory operations and data integrity using LIMS/ELN and relevant software.

Skills

Protein biochemistry

Bioanalytical techniques

GMP experience

Data integrity

Stakeholder management

LIMS familiarity

ELN proficiency

Instrument control software

Microsoft Office

Education

Bachelor’s or postgraduate qualification in analytical biochemistry, chemistry, molecular and cellular biology, pharmaceutical sciences or related discipline

Tools

LIMS

ELN

Instrument control software

Microsoft Office

Job description

CSL Behring in Melbourne seeks an experienced Scientist to join the GMP Analytical Testing team for a 12-month fixed-term period. You will plan and execute GMP analytical testing, support stability programs and assay qualification, and contribute to technology transfer with strong data integrity.

You will collaborate with Quality Assurance and project teams, manage laboratory activities with ownership, and maintain inspection-ready operations using LIMS, ELN, and instrument control software.