Senior Analyst, QC (CGT)

at  Lonza

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.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
The successful candidate will join the Cell, Gene and Therapy division (CGT). This role is responsible for providing technical expertise for all testing techniques and coordinating with the other customers and other departments to deliver projects in a timely manner.

Duties and Responsibilities:

• Provide technical expertise and initiate improvements in the overall environmental monitoring program
• Lead investigation into environmental monitoring excursions and microbial contamination events
• Partner with DIT during cross-functional investigation
• Provide oversight for Environmental Monitoring (EM) gap assessment against Pharmacopeia and industry standards
• Perform microbial and environmental monitoring risk assessment
• 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.
• Ensure timely completion of trend reports
• Perform/ review statistical analysis of EM data
• Perform environmental and personnel monitoring as required
• Lead/ execute method qualification
• Manage/ perform equipment qualification and validation maintenance review
• Lead/ execute continuous improvement project
• Customer and regulatory agency interaction as required
• Source of expertise and provide coaching for rest of staff
• Maintains knowledge of new technologies/ compendia update
• Communicate risks to manager and Head of QC
• Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
• Any other duties as assigned by manager

Requirement:

• Degree in a relevant Science field or Equivalent
• Relevant work experience in Lab experience in a biotech or development services, R&D, healthcare and lifescience field would be advantage
• 5 – 10 years experience in QC
• Demonstrates an ability and desire to learn from experience
• Uses knowledge of his/her business area to make accurate and timelydecisions
• Ensures quality standards are maintained while delivering results
• Bio Assay Area: Understanding and execution of ELISA, potency, PCR and FACS methods.

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

• Provide technical expertise and initiate improvements in the overall environmental monitoring program
• Lead investigation into environmental monitoring excursions and microbial contamination events
• Partner with DIT during cross-functional investigation
• Provide oversight for Environmental Monitoring (EM) gap assessment against Pharmacopeia and industry standards
• Perform microbial and environmental monitoring risk assessment
• 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.
• Ensure timely completion of trend reports
• Perform/ review statistical analysis of EM data
• Perform environmental and personnel monitoring as required
• Lead/ execute method qualification
• Manage/ perform equipment qualification and validation maintenance review
• Lead/ execute continuous improvement project
• Customer and regulatory agency interaction as required
• Source of expertise and provide coaching for rest of staff
• Maintains knowledge of new technologies/ compendia update
• Communicate risks to manager and Head of QC
• Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
• Any other duties as assigned by manage