- Optimization and improvement of technological process and composition of drugs introduced into production.
- Development of the technological process for obtaining solid form pharmaceuticals (tablets, capsules).
- study of the stability of semi-finished products and finished medicines.
- Writing a report on the development of composition and technology.
- Preparation of technological documentation for the registration dossier, technological instructions, regulations, route maps (protocols) per series.
- Participation in scaling up and implementation of technologies at the production site.
- Participation in validation work (knowledge of the main validation stages).
- Writing SOPs, route maps, logging.
- Experience in the position of "Engineer-technologist" / "Technologist" at least 3 years in the field of pharmaceutical development, experience with solid forms.
- Experience in pharmaceutical production in the R&D department.
- It is desirable to have experience in development using innovative approaches.
- Federal laws related to pharmaceutical activities.
- GMP regulations.
- Basics of pharmaceutical development.
- ICH requirements for stability studies, production of samples for pre-clinical and clinical studies, and comparative dissolution test.
- Pharmacopoeias of the Russian Federation and other countries, their requirements for solid medicines, ASF and auxiliary substances.
- Manufacturers of auxiliary substances, ASFs and process equipment.
- New trends in drug development.
- Principles of operation of laboratory process equipment and its types.
- Basics of safety when working with laboratory process equipment.
- Free possession, operation and maintenance of basic laboratory process equipment used in the production of solid dosage forms.
- Independent planning and execution of experimental downloads.
- Correct maintenance of records and preparation of reporting documentation.
- Ability to read and translate technical and specialised literature.