Laboratory Infrastructure Management System Manager (f/m/d)
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time.
For more information, visit www.agcbio.com
AGC Biologics GmbH is currently searching for a LIMS-Manager to support the Quality Control (QC) department. Your main task will be the implementation and maintenance of a LIM system for quality control. Together with the team, you will analyze the laboratory infrastructure and prepare it for the implementation of the LIMS. In parallel, you will start to create users in the LIMS and train the employees in the use of the LIMS. Your Profile, Knowledge, Skills & Abilities:
- Strong motivation to familiarize yourself with a complex laboratory IT infrastructure
- Experience with interfacing instrument software with scientific data management system (SDMS) platforms such as LIMS.
- Experience with analytical method development or working in a Quality control lab.
- Knowledge of cGMP regulations (FDA, EMA) with a focus on computer system validation and Data integrity.
- Strong Quality Mindset
- Work experience in a pharmaceutical environment or a similarly regulated field environment is an advantage
- excellent communication and presentation skills
- very good German and English level (at least B2) are required
- Work permission