Research Scientist (in the field of bacteriology and pharmacology)

Responsibilities: Supervising the conduct of physicochemical studies and biosimilarity studies of biotechnological products; Planning studies, coordinating with laboratories, setting up and monitoring task readiness; Calculating, justifying quantities, and transferring products for study; Drafting study plans and biosimilarity assessment reports; Justifying quality indicators and research methods; Verifying analysis protocols and evaluating research analytical data; Statistical processing of obtained data, justifying statistical differences; Conducting meetings based on the results of conducted studies; Preparing appendices for the Investigator's Brochure; Preparing sections of the dossier for the investigational medicinal product and sections of the registration dossier; Writing explanatory notes on conducted studies; Evaluating registration dossiers and other partner data; Drafting literature reviews; Writing standard operating procedures and instructions within the group's area of activity;

Requirements

Requirements: Higher education (biotechnology, biochemistry, pharmacy); Knowledge of regulatory documentation in the field of development and production of biotechnological products (ICH, FDA, GMP, State Pharmacopoeia of the Russian Federation, FEAEC, EP, USP, EEC Decisions No. 89, No. 77, No. 78); Knowledge of the basic principles and rules for the development, production, and registration of biotechnological medicinal products; Knowledge of the theoretical basis regarding the properties and methods of obtaining monoclonal antibodies, conjugates, enzymes, vaccines, and hormones; Ability to work in search information systems, MS Office, MiniTab, or other software for statistical data processing; Ability to conduct literature and scientific searches; Knowledge of English.

Higher education — specialist degree, master's degree; Experience: 3 years