QC Technical Expert 2
Singapore, Tuas Singapore
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there is 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.
Due to business growth in the Cell & Gene Therapy manufacturing, we are recruiting a QC Technical Expert. The role will act as a key team member of the Quality Control Environmental Monitoring department to support Manufacturing operations in areas of routine monitoring of the production environment as well as dynamic monitoring of critical operations. The Technical Expert will also provide on-time, high quality results to meet Manufacturing needs.
- Provide technical expertise in ELISA, PCR, Cell Count and Viability, FACS and Karyology
- Lead investigation pertaining to Bioassay events
- Partner with deviation investigation team during cross-functional investigation
- Author and review Change Controls, Deviations/Investigation as well as Test Methods/ SOPs
- Review of laboratory data (both internal and external)
- Responsible for inspection readiness program as assigned by manager.
- Lead/ execute method qualification
- Manage/ perform equipment qualification and validation maintenance review
- Lead/ execute continuous improvement project
- Perform QC test as required
- Customer and regulatory agency interaction as required
- Manage 3 to 5 QC Analysts and provide expertise and coaching for rest of staff
- Maintains knowledge of new technologies/ compendia update
- Communicate risks to manager and Head of QC
- Any other duties as assigned by manager.
- Degree in a relevant Science field or Equivalent
- Extensive experience in Bioassay testing such as ELISA, PCR, Cell Count and Viability
- Exposure to FACS and Karyology will be helpful
- Understands the theory and practical aspects of method and equipment qualification
- Strong ability to work and influence across different functional teams
- Highly motivated and ability to work under challenging timelines
- Excellent technical writing skills
- Able to communicate effectively in professional manner with customers
- Relevant experience and accomplishment to dictate final position for which the candidate may qualify
- Well versed in cGMP regulations
- Good problem solving and analytical skills
- Good communication 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 achieve 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.