Lead Analyst, Quality Control (Chromatography)

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

The QC Analyst will be responsible for Biochemistry Area in the QC Lab to support Lot Release activities

What you’ll get

• An agile career and dynamic working culture in a global life sciences leader.

• An inclusive and ethical workplace that values diversity and integrity.

• Competitive compensation programs that recognize high performance.

• Professional growth opportunities through cross-functional projects and global exposure.

• Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.

• Company transport provided from designated MRT locations to and from the Tuas site.

• Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits

What you’ll do:

• 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

What we’re looking for:

• 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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.