Projects CTF LM+ A.A. 2021/2022
Chemical Research and Development aimed at achieving processes with the target of: maximizing yield and therefore reducing raw material and process costs, obtaining products and/or intermediates with the required quality or already existing specifications for generic products, or meeting the needs requested by ACS Dobfar customers in the case of Custom Synthesis projects. The objective of the internship will be to acquire: familiarity with organic chemical synthesis using the most common homogeneous and/or heterogeneous phase synthesis techniques and final purification/isolation of the obtained products. Characterization of these products using different techniques such as: NMR, ESI-MS, HPLC, UV-vis, spectrofluorimetry. Kinetic analysis using UV-Vis and HPLC-UV.
The intern will be placed in the Chemical Laboratory. The objective of the internship will be the qualification of equipment in a GMP regulated environment (photometers, NIR/RAMAN spectrophotometers, HPLC). The intern will participate in all steps of instrument qualification, with particular reference to the qualification of analytical methods according to the ICH approach and software qualification as required by CFR 21 part 11; they will also be responsible for drafting the usage, calibration, and management documentation for the equipment. In addition to the specific thesis project, the intern will work in a production plant and will rotate within the Quality group areas (microbiological laboratory, validations, quality assurance), interfacing with the main company functions; this will provide an overview of the various roles that make up the Quality group of a pharmaceutical company and will gain experience in the different aspects necessary for drug production and control.
The intern will be placed in the Chemical Laboratory. The intern will participate in the development of a risk assessment for the application of "ICH Q3D" to the control of elemental impurities in the finished product; to this end, they will conduct analyses using ICP-MS techniques to gather information on the content of elemental impurities in the production process, raw materials, and the product itself. In addition to the specific thesis project, the intern will work in a production plant and will rotate within the Quality group areas (microbiological laboratory, validations, quality assurance), interfacing with the main company functions; this will provide an overview of the various roles that make up the Quality group of a pharmaceutical company and will gain experience in the different aspects necessary for drug production and control.
The intern will be placed in the Quality Assurance department team of the pharmaceutical workshop, specialized in the production and control of injectable drugs. The objective of the internship is the training of a professional in the field of quality; initially, the intern will be instructed on company procedures relevant to quality assurance, followed by hands-on experience in the department, in collaboration with experienced colleagues.
The intern, placed in the R&D area, will conduct a market analysis to identify market opportunities for the proposal of new dietary supplements. They will study the formulation rationale and communication materials. The intern will develop the product in the laboratory with company technicians and follow the initial phase of industrialization and scale-up.