Biochemistry QC Analyst - Lot Release & Methods

Lonza Group Ltd.; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Competitive compensation programs

Medical insurance with family coverage

Company transport from MRT to Tuas

Employee benefits access

Job summary

Lonza is seeking a QC Analyst to support the Biochemistry area in the QC Lab and Lot Release activities. You will prioritize analytical testing, perform final product and in-process testing, and ensure data integrity under cGMP.

You will execute ELISA, PCR, CE, SDS-PAGE and related assays, maintain standards, troubleshoot methods, and contribute to method transfer and validation. Strong documentation and teamwork are essential.

Qualifications

• Degree or higher with experience in QC/Quality in biopharmaceuticals.
• Familiarity with FDA/EMA/ICH guidelines and GMP quality systems.
• Strong planning, prioritization and documentation skills.
• Good communication and interpersonal abilities.
• Analytical, meticulous and quality-focused mindset.
• Team player who can work independently with safety and timeline discipline.
• Openness to new challenges and continuous improvement.

Responsibilities

• Prioritize and perform analytical testing to meet business timelines.
• Test final product, in-process, and stability samples per SOPs and methods.
• Document and review results in compliance with cGMP and data integrity requirements.
• Execute assays such as ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency, and other physicochemical methods.
• Support lab operations: housekeeping, equipment upkeep, inventory, autoclaving, and glassware management.
• Prepare and maintain standards/reagents per GMP requirements.
• Troubleshoot analytical methods and equipment issues.
• Participate in equipment qualification and maintenance.
• Support or lead OOS and deviation investigations; draft reports.
• Train others on test methods.
• Contribute to method transfer and validation activities.
• Author change controls, test methods, and SOPs.

Skills

QC testing

Elisa

PCR

CE

SDS-PAGE

IEF/icIEF

Documentation

Troubleshooting

Method transfer

SOPs

Teamwork

Attention to detail

Communication

Independence

Education

Degree or higher in a relevant field

Tools

GMP knowledge

Job description

Lonza is seeking a QC Analyst to support the Biochemistry area in the QC Lab and Lot Release activities. You will prioritize analytical testing, perform final product and in-process testing, and ensure data integrity under cGMP.

You will execute ELISA, PCR, CE, SDS-PAGE and related assays, maintain standards, troubleshoot methods, and contribute to method transfer and validation. Strong documentation and teamwork are essential.