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.
This role is responsible for the supervision of all testing techniques and scheduling of testing with coordinating with the other departments delivering samples to ensure timely delivery of results. Role is also required to supervise the review of laboratory data (both internal and external) and the closeout of deviations.
Microbiology/Environment Monitoring 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.
Key responsibilities:
- 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.
- To perform QC test as required.
- Any other duties as assigned by your Manager.
Key requirements:
- Degree in a relevant Science field or Equivalent.
- Substantial work experience, preferably lab experience in a biotech QC related field.
- Supervisory experience, demonstrate solid leadership skill and ability to lead a team.
- Experienced in technology transfer, method transfer and analytical method validation
- Experienced in environmental monitoring of cleanrooms, aseptic process simulations and microbiological tests such as bioburden, endotoxin and sterility test.
- Good report writing skill and able to lead/author investigation report independently.
- Demonstrate troubleshooting and problem-solving skills.
- Demonstrate effective communication 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.
R61773
