(Senior) Technician QC Microbiology

at  Batavia Biosciences BV

• Growing and dynamic Biotech company
• Building a new GMP-facility
• Setting up and maintain the QC Micro lab

ABOUT THE COMPANY

Batavia Biosciences significantly contributes to ease human suffering from infectious diseases, cancer, and rare diseases by leveraging our innovative technologies and in-depth know-how. We 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 the CJ CheilJedang 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 (Senior) Technician QC Microbiology.

Production and lab environment

• 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 with EM, Sterility, Bioburden, Endotoxin and Annex1
• 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
• Good command of English and Dutch