About this role
Main objective Aseptically manufactures clinical grade extracellular vesicles (EVs)-based biotherapeutics in an ISO 7 / Grade B cleanroom compliant with cGMP. ️ Key responsibilities Material cleaning, disinfection and supply to cleanroom areas. Operates in grade A and/or B during aseptic process simulations. Support and verify aseptic operations during clinical production of master banks, working cell banks and EVs products. Perform aseptic manipulations in grade A biosafety cabinets for clinical production of master banks, working cell banks and EVs products. Perform routine and process-related environmental monitoring. Perform routine facility and equipment cleaning and disinfection. Document manufacturing activities and observations in the applicable records. Contemporaneously report deviations from the established standard operating procedures to supervisor and support in investigations. Traits and qualities Highly precise and organized professional Proactive hands-on mentality Responsible and autonomous GMP compliance mindset Skills and expertise Proven expertise with adherent mammalian cell culture. Knowledgeable about aseptic techniques. Professional conversation skills in English (at least B2). Education At least one of the following: A Bachelor's degree (B.Sc.) in Biology, Biotechnology, Biochemistry, Pharmacy, or a closely related scientific field. Experience in aseptic ATMP or biotherapeutics manufacturing. A specific technical training targeted for the biotech industry. Region Must be eligible to work in the EU. Must be able to commute daily to Liège.