Job Description

 

Tasks:

  • 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.

 

Requirements:

  • 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.

 

Knowledge:

  • 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.
 
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Contact

Anastasia Soldatkina
+7 495 935-86-06