Posted 4 days ago
Lead Analyst, Quality Control (Product Testing)
AI Summary
Lead Analyst in Quality Control for product testing at Lonza Biologics, responsible for biochemistry area testing, lot release support, and compliance with cGMP and data integrity requirements.
About this role
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
What you’ll do:
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.
Ready to shape the future of life sciences? Apply now.
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