- New GMP-facility
- Setting up a new team
- Setting up new QC Microbiology labs
- Setting up and maintain the QC Micro lab
- Develop and implementation of QC microbiology test methods such as for Sterility, Bioburden
• Proficient in generating SOPs, work instructions and other GMP documentation - Development of a risk based facility Environmental Monitoring (EM) program
- Development of a risk based EM program for production activities
- Establishing all QC Micro related SOPs and work instructions
- Perform data verification, data review and review of GMP documentation
- Train and mentor others on multiple QC micro test methods
- Experience within a QC microbiology lab environment
- Experience in method transfer/verification of QC Micro test methods
- Experience with training requirements and training of analysts
- Familiar with GMP, associated regulations and pharmacopoeias
Teamlead QC Microbiology - Leiden, Nederland - Talent Associates
Beschrijving
Our client significantly contributes to ease human suffering from infectious diseases, cancer, and rare diseases by leveraging our innovative technologies and in-depth know-how. They do this for viral vaccines and cell and gene therapies at all stages of the development trajectory, from the transition into early clinical studies, to navigating late-stage clinical development and entering commercial manufacturing at higher speed, reduced costs, and with increased success. The company operates state-of-the-art development and manufacturing facilities in Europe and the US and, as part of a global family, is building a strong position in global health with its strategic partners worldwide. For our new biomanufacturing facility in Leiden we are looking for a Team lead QC Microbiology.
About the role Production and lab environment
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