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
APLIKUJ TERAZ

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Dodano: 2025-10-22
KRKA Polska Sp. z o.o.

Technik analityk ds. kontroli jakości

Lokalizacja: mazowieckie / Warszawa

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