Analytical Expert

1 tydzień temu

Warszawa Wielkopolskie, Polska Polpharma Pełny etat

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.

We offer:

  • Stable employment in a modern and dynamically-developing pharmaceutical company operating in international markets
  • Contract of employment
  • Employee relocation package
  • Basic salary + bonuses
  • Private medical care
  • Subsidy for meals (350 PLN net)
  • Multisport card
  • Possibility to join group life insurance
  • Employee Pension Program
  • Points in the Motivizer cafeteria

Requirements:

  • Master's 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

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