Associate Manager, QC
2 weeks ago
Singapore, Tuas Singapore
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.
Associate Manager, QC you will be responsible for overseeing the successful transfer of biochemistry analytical methods into the QC laboratory. The role ensures operational excellence in method validation, data integrity, and regulatory compliance, while also supervising day-to-day laboratory operations and personnel development.
Key Responsibilities
- Supervises and schedules testing activities for biochemistry methods including ELISA, qPCR, CE-SDS, icIEF, gel-based methods, and cell-based assays.
- Ensure all testing is performed and reviewed as required by the business.
- Ensure all testing personnel are trained and up-to-date on current Good Manufacturing Practices (cGMP).
- Review laboratory data, logbooks, and GMP documentation such as deviations, change controls, and investigations.
- Performs and/or reviewed investigation in to Out of Specification results.
- Author and review SOPs, test methods, specifications, change controls, and deviation reports.
- Interact with customers and regulatory agencies as required.
- Coordinate with cross-functional departments to resolve issues related to testing, maintenance, compliance, and documentation.
- Champion data integrity practices and lead initiatives to strengthen data management processes.
- Conduct performance evaluations and provide coaching and development for direct reports.
Key Requirements
- Bachelor's or Master's degree in Biochemistry, Biotechnology, or related discipline.
- Minimum 8 years of experience in QC or analytical labs in a GMP environment.
- Prior experience in tech transfer and method validation preferred.
- Strong understanding of cGMP, data integrity, and regulatory compliance.
- Leadership experience with ability to mentor and develop team members.
- Excellent communication and organizational skills.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Reference: R68199
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