Senior Lab Manager - GMP/GLP, HPLC & Method Development

Pharma - Contract Manufacturer; Sydney; On-site; AUD 120,000 - 150,000; Full time

Job summary

Pharma - Contract Manufacturer in Smithfield NSW is seeking an experienced Lab Manager to lead analytical operations. The role requires hands-on expertise with HPLC and other techniques, plus extensive experience in method development and validation.

You will train staff, ensure GMP/GLP compliance, manage lab audits, and drive quality control from raw materials to finished products, while maintaining accurate documentation and instrument calibration.

Qualifications

• 7+ years hands-on experience with HPLC and other analytical techniques.
• Experience in method development and validation for raw materials and finished products.
• Proven ability to train staff and ensure GMP/GLP compliance.

Responsibilities

• Perform QC assignments including raw material, in-process and finished product testing.
• Create and update QC documents, specifications and test methods.
• Train staff and ensure compliance with regulatory requirements.
• Manage lab and handle regulatory audits.
• Develop and validate analytical methods for materials and products.

Skills

Lab management

HPLC

Analytical method development

Regulatory compliance

GMP/GLP

Tools

GC

FTIR

UV-Vis

ICP-OES

Job description

Pharma - Contract Manufacturer in Smithfield NSW is seeking an experienced Lab Manager to lead analytical operations. The role requires hands-on expertise with HPLC and other techniques, plus extensive experience in method development and validation.

You will train staff, ensure GMP/GLP compliance, manage lab audits, and drive quality control from raw materials to finished products, while maintaining accurate documentation and instrument calibration.