Senior Chromatography QC Lead — Drive Biotech Quality

Lonza; Singapore; Presencial; SGD 90.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Transport provided from MRT to Tuas

Descripción de la vacante

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.

Formación

• 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

Responsabilidades

• 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

Conocimientos

Quality control

GMP knowledge

Documentation

Analytical testing

Team player

Educación

Bachelor's degree in Biochemistry

Herramientas

ELISA

PCR

SDS-PAGE

icIEF

Descripción del empleo

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.