Lab Manager, Microbiological Lab
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.
Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
As Lab Manager, Microbiological Lab, you will supervision of all microbial techniques with regards to the testing of in-process, bulk release, and GMP raw material, also responsible for the management of the
microbial lab team to ensure the compliance with cGMP requirement.
- To perform QC test as required.
- Supervising the review of laboratory data (both internal and external) and the closeout of deviations.
- Scheduling of testing - coordinated with the other departments delivering samples to ensure timely delivery of results.
- Supervision of all testing techniques.
- Responsible for ensuring that all personnel involved in testing are trained in basic cGMP training and are getting routine updates in cGMP information and training.
- Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs.
- Responsible for data and logbook review.
- Customer and regulatory agency interaction as required.
- Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance and documentation issues are resolved
- Evaluations of vendors via vendor audits, comprehensive testing and review of quality performance.
- Perform report writing (Example: Deviations/Investigations/Trending).
- Involved in equipment qualification.
- Perform annual performance evaluations of all direct reports.
- Provide continued coaching and developing of subordinates to help them meet both their career and personal development goals and to ensure a cohesive, productive and highly motivated team.
- Any other duties as assigned by your Manager.
- Specific Areas of Responsibility:
- Microbiology/EM Area:
- Supervision of all microbiological and Environmental Monitoring techniques including.
- QC testing of environmental, raw materials, in-process and final product samples. QC testing includes but is not limited to: Total particulates, Air viable, Surface viable, Bioburden, Endotoxin, Growth Promotion, Biological Indicator Check Testing and Microorganism Identifications.
- Responsible for tracking and review of virus and mycoplasma testing for all products (as required).
- Responsible for tracking and review of QC cell banking activities.
- Bachelor or above, majoring in Microbiology or relevant area
- Extensive working experience in Microbial Lab Management in biologics / Pharma business, technical experience in Mammalian Cell Culture Manufacturing Environment is preferred.
- cGMP Environment in related QC Field.
- Solid Management experience.
- Experience Participating in Domestic and International Regulatory Inspections is required.
- Experience working in a CMO (Contract Manufacturing Facility) and having ability to understand the requirements and expectation of clients in a customer service/satisfaction based organization is preferred.
- Experience in Corporate Quality System initiatives (Six Sigma, Lean, TQM, etc.) a plus.
- Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, Project, PowerPoint
- Good Written & Oral English skill
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.