- knowledge of CTD requirements (ICH Topic M 4 Q) for the structure and content of Modules 2.3 and 3 of MAAD;

- compilation and modification of sections of Module 3 “Quality”;

- knowledge of EMA and FDA guidelines, Ph. Eur. and USP monographs on the Risk Evaluation for N-Nitrosamines in finished medicinal product;

- preparation of N-Nitrosamines Risk Evaluation in finished medicinal product (Module 3.2.P.5.5 “Characterization of Impurities” and Module 1 of MAAD);

- knowledge of Ph. Eur. and USP monographs, EMA and FDA guidelines on the polymorphism study of the active pharmaceutical ingredients in finished medicinal product;

- preparation of report on the polymorphism of the active pharmaceutical ingredients in finished medicinal product (Module 3.2.P.2.2.3 “Physicochemical and Biological Properties” of MAAD);

- knowledge of State Pharmacopoeia of Ukraine and USP monographs on validation of analytical procedures;

- preparation of reports on the validation of analytical methods “Determination of active substance particles size” and “Determination of nitrosamine impurities content in finished medicinal product” (Module 3.2.P.5.3 “Validation of Analytical Procedures” of MAAD);

- knowledge of approaches to compatibility study of the active substance(s) with excipient(s) in developing medicinal product;

- preparation of report on the components compatibility study in developing medicinal product (Module 3.2.P.2 “Pharmaceutical Development” of MAAD);

- knowledge of EMA guidelines on “Stability testing of new Drug Substances and Products” and “Stability testing of existing active substances and related finished products”;

- preparation and modification of Module 3.2.P.8 Stability.

- preparation of tables based on stability results of developed medicinal products;

- calculation of medicinal products amount required to study their stability within the shelf life;

- preparation of supporting documents for stability study of developed medicinal products;

- loading and removing medicinal products from climate chambers to study their stability;

- working in the 1C accounting software;

- control and accounting of reagents, consumables and reference substances;

- ordering reagents, consumables and on-line accesses to Ph Eur and USP;

- contract management and business correspondence with company partners.

- work with scientific databases;

- scientific projects development;

- preparing scientific articles, patents and presentations;

- synthesis of inorganic materials and their testing by adsorption and spectral techniques (GC, XRPD, DSC-TGA-MS, IR spectroscopy, TPR-H2, TPO-CO2).

Practical course of General and Inorganic Chemistry, supervision of Master students.