Lead Analyst, Quality Control (Chromatography)

Lonza; Singapore; On-site; SGD 90,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Transport provided from MRT to Tuas

Job summary

Lonza is seeking a Lead Analyst, Quality Control (Chromatography) to support Lot Release activities within the Biochemistry area of the QC Lab. You will prioritize and perform analytical testing, execute ELISA/PCR/CE/SDS-PAGE/IEF, and ensure results are documented per cGMP standards.

You will participate in method transfer, validation, and investigations of OOS/deviations, while training staff and supporting general lab operations at the Tuas site.

Qualifications

• Degree in Biochemistry with 5+ years of QC/Quality experience in biopharma
• Experience in QC testing and data integrity
• Familiarity with FDA/EMEA/ICH guidelines and GMP systems
• Strong planning, prioritization, and documentation skills
• Good communication and interpersonal abilities

Responsibilities

• Prioritize and perform analytical testing to meet timelines
• Test final product, in-process, and stability samples per SOPs/methods
• Document and review results in compliance with cGMP and data integrity
• Execute methods such as ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency
• Support general lab operations: housekeeping, equipment upkeep, inventory, autoclaving, glassware
• Troubleshoot analytical methods and equipment issues
• Participate in equipment qualification and maintenance
• 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

Quality control

GMP knowledge

Documentation

Analytical testing

Team player

Education

Bachelor's degree in Biochemistry

Tools

ELISA

PCR

SDS-PAGE

icIEF

Job description

Lead Analyst, Quality Control (Chromatography)

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.

Reference: R80506

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.