Lead Analyst, Quality Control

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

Requirements

• 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
• Ready to shape the future of life sciences?

Additional Information

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

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Company Intel

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