Section Manager, QC
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.
The role will be responsible for supervision of all biochemical, analytical, and chemical techniques with regards to the testing of in-process, bulk release, and stability product samples. QC testing includes but is not limited to: SDS-PAGE, ELISA, UV, Osmolality, HPLC, CE, pH and Conductivity, Potency methods, Appearance and physiochemical methods.
The role will also function as the main coordination between QC testing groups and the manufacturing floor personnel.
- 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
- 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
- Good understanding of principle of Chromatographic testing, especially familiar with various HPLC methods for protein sample testing
- Familiar with Empower software
- Experience of analytical method transfer and/or method validation is preferred
- Good report writing skill and able to lead/author investigation report independently
- Demonstrate troubleshooting and problem solving skills
- Demonstrate effective communication skill.
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.