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’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. You will supervise the review of laboratory data (both internal and external) and the closeout of deviations and supervise all testing techniques.
- To perform Quality Control 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 Current Good Manufacture Practices training and are getting routine updates in Current Good Manufacture Practices information and training
- Author and review Change Controls, Deviations/Investigation as well as Test Methods,
Specifications and Standard Operation Procedure
- 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
- Degree/Diploma in a relevant Science field or Equivalent
- Relevant work experience preferably Lab experience in a biotech or medically related field
- Well verse in Current Good Manufacture Practices regulations
- Knowledge area specific responsibilities
- Good problem solving and analytical skills
- Good communication skills
- Strong leadership skills
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.