The quality of the drugs we produce is of the highest priority in our company. As a Technical Assistant (m/f/d) at Minaris Regenerative Medicine GmbH, you will examine the quality and safety of state-of-the-art cell and gene therapies.
Your core task is the planning, execution, and documentation of analytical tests of starting materials, packaging material, intermediates, and final products. You will also receive full training for the analytical methods and perform the analyses according to the valid test instructions. Furthermore, you will work closely with our Quality Control Managers and gain insight into the theoretical basics by assisting in the preparation of work instructions, test specifications and reports, as well as in validations and qualifications.
In addition, we offer you the opportunity to take responsibility for projects and become a method trainer for the technical staff. Our technical assistants (m/f/d) are aware of your responsibility for patients and work with passion to maintain the highest quality standards. We offer you an intensive introduction into the field of work, a career path specifically for technical assistants and a competent, motivated and friendly team.
As Quality Control Manger (m/f/d) at Minaris Regenerative Medicine GmbH, you will ensure that the quality control of the cell and gene therapies we manufacture meets the highest standards.
You will support the Quality Control Technical Assistants with your expertise and will be responsible for planning, performing, and documenting the analysis of the cell-based medicinal products and investigational medicinal products manufactured by us in accordance with Good Manufacturing Practice (GMP). To this end, you will prepare, review and approve various quality-related documents such as work instructions (SOP), risk analyses, and plans and reports for validation of laboratory equipment and software.
Your in-depth understanding of cellular analytics and GMP guidelines will enable you to evaluate the impact of production changes and corrective actions on the pharmaceutical quality of the product. Your versatile tasks also include the training of employees. You will be in close contact with our international customers and external laboratories and will be the technical contact for audits and inspections. Our Quality Control Managers have a high sense of responsibility and attention to detail.