PLeanbio is a leading Biopharmaceutical CDMO offering end-to-end services in the field of recombinant proteins, mRNA and pDNA. With over a decade of expertise, we have a proven track record in development and manufacturing of therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA and pDNA. /ppbr/ppLeanbio has already worked with over 100 candidates over these years, some already in late clinical stages. Leanbio is expanding its development and manufacturing capabilities with a new GMP site in Barcelona with over 4,000 sqm. and three manufacturing areas: one for mammalian expression systems up to 2000L, another for microbial and yeast up to 1000L, and a third are for mRNA up to 50L. /ppbr/ppThe new facility includes state-of-the-art development laboratories, oustanding Quality control rooms and warehouse. Leanbio is a global service provider for the development and manufacturing of biologics. Our commitment to excellence is evident in everything we do: /ppbr/pulliPrioritizing customer satisfaction. /liliProviding cutting-edge end-to-end services. /liliUtilizing state-of-the-art facilities. /liliOffering extensive expertise in biologics. /li /ulpbr/ppWe are looking for a new person to join the QC as an analyst to work in our brand new facilities in Sant Quirze del Vallès: /ppbr/ppstrongMAIN RESPONSIBILITIES: /strong /ppbr/pulliPerform routine and non-routine physicochemical analyses of raw materials, intermediates, and finished products using techniques such as:HPLC (High-Performance Liquid Chromatography), Karl Fischer titration (moisture determination), FTIR / IR (identification of materials), Loss on Drying (LOD), Potentiometric titrations, Residue on Ignition (ROI), pH, conductivity, osmolality, TOC, etc. /liliCarry out sampling and analysis of water systems, including:Water for Injection (WFI) /liliSupport environmental monitoring activities, including:surface and air sampling in classified areas. /liliEnsure strict adherence to GMP and ALCOA++ data integrity principles, maintaining complete, accurate, and traceable documentation. /liliDocument all activities clearly and contemporaneously in lab notebooks, logbooks, or electronic systems (e.g., LIMS), in compliance with internal SOPs. /liliParticipate in quality system activities, such as investigation of OOS / OOT results reporting of deviations and support in CAPA implementation. /liliMaintain and calibrate laboratory equipment, performing routine checks and informing of any malfunction or need for maintenance. /liliFollow safety protocols and contribute to keeping the lab in a clean condition at all times. /liliCollaborate with cross-functional teams, including QA, production, and validation, when needed. /li /ulpbr/ppstrongREQUIREMENTS: /strong /ppbr/pulliAdvanced Training in Laboratory Analysis and Control with 2–5 years of experience in Quality Control in a GMP-regulated pharmaceutical environment. /liliPractical experience in physicochemical testing including HPLC, Karl Fischer, IR, Loss on Drying, potentiometric titrations, and Residue on Ignition. /liliSkilled in sampling and analysis of pharmaceutical water systems (WFI, Purified Water) following USP/EP methods. /liliFamiliarity with environmental monitoring in cleanroom environments is an asset. /liliStrong knowledge of ALCOA++ principles and GMP documentation practices. /liliExperience with quality systems (OOS, deviations, CAPAs, change control). /liliProactive team player with good organizational skills and the ability to work independently. /liliFluent in Spanish with basic to intermediate English communication skills (reading/writing preferred). /li /ul