Development, validation, and transfer of new analytical methods for pharmaceutical substances, medicinal products, and medical devices, including multi-component products, in accordance with the latest ICH and FDA requirements;
Preparation of reports on the assessment and review of literature data for the feasibility study of projects in the field of analytics;
Participation in the development of quality specifications for medicinal products and medical devices based on current guidelines;
Preparation of analytical documentation in accordance with internal procedures (including reports containing risk analysis elements);
Participation in the preparation of registration documentation modules for the active substance and the finished product.
Our requirements:
Masters degree (preferred: chemistry, chemical technology, biotechnology, or related fields), PhD is a plus;
Knowledge of requirements for the development of products containing oligonucleotides and polypeptides in accordance with the latest EMA and FDA guidelines;
Practical knowledge of classical and instrumental analytical techniques - HPLC, UHPLC, LC-MS, NMR, IR, potentiometric titration, as well as techniques for assessing the structure of biological systems (very good knowledge of MS detection techniques);
Experience in establishing contacts and cooperating with external units, especially scientific institutions;
Professional experience in a similar position: at least 3 years, allowing for the implementation of highly specialized research projects and problem-solving in projects;
Knowledge of ICH/FDA guidelines; registration documentation and principles of working in accordance with the GMP system;
Very good knowledge of English and mathematical statistics;
Ability to work in a team and good organization of own work;
Openness to changes, creativity, especially in proposing new project solutions or improving work in the laboratory;
Knowledge in the field of biotechnological formulations and quality requirements for sterile, liquid drug forms and participation in multidisciplinary research teams is a plus
