Lead Analyst, Quality Control (Chromatography)

About the role

Lonza is hiring a Lead Analyst, Quality Control (Chromatography) for its Tuas site in Singapore. The QC analyst supports the Biochemistry area of the QC lab and is responsible for lot release activities.

Key responsibilities

• Prioritize and perform analytical testing to meet business timelines
• Test final product, in-process and stability samples according to SOPs and methods
• Document and review results in line with cGMP and data integrity requirements
• Run 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 and reagents to GMP requirements
• Troubleshoot analytical methods and equipment issues, and participate in equipment qualification and maintenance
• Support or lead OOS and deviation investigations, draft reports, and train others on test methods
• Contribute to method transfer and validation, and author change controls, test methods and SOPs

Required profile

• Degree or higher with 5 years of QC/quality experience in biopharmaceuticals
• Lab experience in biotech or medically related fields preferred
• Familiarity with FDA, EMEA, ICH guidelines and GMP quality systems
• Planning, prioritization and documentation skills, good communication and interpersonal abilities
• Analytical, meticulous and quality-focused mindset, able to work independently with strong safety and timeline discipline

What we offer

• Competitive compensation programs recognizing high performance
• Comprehensive medical insurance with the option to include family members at partially subsidized premiums
• Company transport from designated MRT stations to and from the Tuas site
• Full employee benefits suite and professional growth through cross-functional projects and global exposure