Lead Analyst, Quality Control (Product Testing)

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Medical insurance

Company transport from designated MRTs

Professional growth opportunities

Job summary

Lonza Singapore is seeking a Lead Analyst in Quality Control (Product Testing) to support Lot Release activities in Biochemistry, with hands-on analytical testing and method execution.

You will perform ELISA, PCR, CE, SDS-PAGE, and other assays, ensure GMP compliance, document results, participate in validations, OOS investigations, and training, within a collaborative, fast-paced environment. The role offers professional growth, cross-functional exposure, and a safety-focused culture.

Qualifications

• Degree or higher in biochemistry/quality-related field with 5+ years QC experience in biopharma.
• Lab experience in biotech/healthcare settings is preferred.
• Familiarity with FDA/EMEA/ICH guidelines and GMP systems.
• Strong planning, documentation, and interpersonal skills.

Responsibilities

• Prioritize and perform analytical testing to meet timelines.
• Test final product, in-process, and stability samples per SOPs.
• Document and review results in compliance with cGMP and data integrity.
• Execute methods such as ELISA, PCR, CE, SDS-PAGE, and related assays.
• Support general lab operations, equipment upkeep, inventory, autoclaving.
• Prepare standards/reagents and troubleshoot assay/equipment issues.
• Participate in equipment qualification/maintenance and OOS investigations.
• Draft reports, change controls, test methods, and SOPs; train others.

Skills

QC knowledge

Biopharmaceutical experience

Analytical testing

Documentation

Communication

Education

Bachelor's degree in Biochemistry/Quality

Tools

ELISA

PCR

CE

SDS-PAGE

IEF/icIEF

Job description

Lead Analyst, Quality Control (Product Testing)

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.

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.