Lead QC Analyst, Chromatography — Biochem Growth & Impact

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Medical insurance

Company transport from MRT

Career growth

Employee benefits

Job summary

Lonza Biologics Tuas Pte Ltd is seeking a QC Analyst to support the Biochemistry area in the QC Lab for Lot Release activities. The role emphasizes analytical testing, documentation, and cGMP compliance.

You will perform ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency, and other physicochemical assays, while contributing to method transfer, validation, and deviation investigations. Strong data integrity and teamwork are essential.

Qualifications

• Degree or higher with 5 years of QC/Quality experience in biopharmaceuticals.
• Preferably lab experience in biotech or medically related fields.
• Familiarity with FDA, EMEA, 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 strong 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 methods such as ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency, and other physicochemical assays.
• Support general lab operations: housekeeping, equipment upkeep, inventory, autoclaving, and glassware management.
• Prepare and maintain standards/reagents based on 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/Quality experience

Planning & documentation

Independent worker

Communication

GMP knowledge

Education

Bachelor's degree or higher in Biochemistry/related field

Tools

ELISA

PCR

CE

SDS-PAGE

IEF/icIEF

Potency assays

Job description

Lonza Biologics Tuas Pte Ltd is seeking a QC Analyst to support the Biochemistry area in the QC Lab for Lot Release activities. The role emphasizes analytical testing, documentation, and cGMP compliance.

You will perform ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency, and other physicochemical assays, while contributing to method transfer, validation, and deviation investigations. Strong data integrity and teamwork are essential.