University of Siena

What you'll study

This master's focuses on the technologies, regulatory frameworks and sustainability principles needed to produce pharmaceutical biologicals and advanced therapeutic agents at industrial scale. Core taught topics typically include upstream bioprocessing (cell culture, fermentation), downstream processing (purification, formulation), bioprocess engineering and scale-up, quality management and Good Manufacturing Practice (GMP).

Complementary subjects emphasise sustainability and innovation: green chemistry and biocatalysis, lifecycle assessment of biopharmaceuticals, process intensification and continuous manufacturing. Students also study regulatory affairs and pharmacovigilance for biologics, analytical methods for biologics (bioassays, HPLC, mass spectrometry), and bioinformatics approaches relevant to product characterisation.

The programme combines lectures and practical laboratory training in pilot-scale facilities, workshops on quality systems and regulatory compliance, and project work. A substantial research project or industrial internship gives hands-on experience in process development, scale-up, validation or sustainability assessment for real-world pharmaceutical or biotech operations.

Entry requirements

Applicants normally hold a bachelor’s degree or equivalent in biotechnology, molecular biology, biochemistry, chemistry, pharmacy or chemical/biomedical engineering with appropriate coursework in biology and chemistry. Admissions look for evidence of quantitative skills and laboratory experience relevant to bioprocessing.

Applicants whose first language is not English or Italian will be asked to demonstrate language proficiency; requirements depend on the language of instruction for the intake. Additional documents typically requested include academic transcripts, a CV, a personal statement outlining research and career interests, and references. Candidates with relevant professional experience in industry or research may be given favourable consideration.

Career prospects

Graduates are prepared for roles across the pharmaceutical and biotechnology value chain where sustainable, compliant manufacture of biological products is required. Typical career paths include process development scientist, downstream/upstream process engineer, production manager, quality assurance/quality control specialist, regulatory affairs officer, validation engineer and sustainability or environmental compliance specialist.

Alumni also move into roles with contract manufacturing organisations (CMOs), contract research organisations (CROs), vaccine and biologics producers, medical biotechnology start-ups, and regulatory bodies. The programme’s emphasis on scale-up and sustainability is increasingly sought after by employers aiming to reduce environmental impact while maintaining regulatory compliance.

Why study at University of Siena

The University of Siena offers a combination of historic academic strengths and active research in molecular and applied life sciences. Students benefit from well-equipped teaching and pilot-scale laboratories and from collaborations between university departments and regional biotech and pharmaceutical companies in Tuscany.

The university places emphasis on applied training, enabling students to undertake internships and project collaborations with industry partners and research centres. Small-group teaching, access to research-active faculty and links to clinical and industrial laboratories support both academic development and employability for graduates seeking technical and managerial roles in sustainable pharmaceutical biotechnology.