Praca: Analytical Expert
Twój rozwój. Nasza wspólna misja.Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.
Szukamy osoby na stanowisko:
Analytical Expert
Miejsce pracy: Warszawa
Your responsibilities:
- 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
We offer:
- Employment contract
- Private healthcare
- Life insurance
- Multisport card
- Special occasion bonus
- Christmas packages for children
- One extra day off
- Retirement plan