ppLeanbio 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. /p pLeanbio 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. /p pThe new facility includes state-of-the-art development laboratories, oustanding Quality control rooms and warehouse. Leanbio is a integral service provider for the development and manufacturing of biologics. Our commitment to excellence is evident in everything we do: /p ul liProviding cutting-edge end-to-end services. /li liOffering extensive expertise in biologics. /li /ul pWe are looking for a new person to join our Quality Control team as a Bioassay Technician. /p h3MAIN RESPONSIBILITIES /h3 ul liExecution and supervision of protein analysis for evaluating the quality attributes of biotech products. /li liEnsure strict compliance with GMP standards and ALCOA++ data integrity principles, keeping complete, accurate, and traceable documentation. /li liDocument all activities clearly and accurately in lab notebooks, analysis records, or electronic systems (e.g., LIMS), following internal procedures. /li liManage processes in the QC Lab. /li liMaintain the inventory and control of reagents and consumables,



ensuring their availability and proper storage conditions. /li liParticipate in quality system activities, such as investigating OOS/OOT results, reporting deviations, and implementing CAPA. /li liManage the calibration and qualification of laboratory equipment, performing routine checks and reporting any malfunctions or maintenance needs. /li liEnsure compliance with safety protocols and always keep the lab clean. /li liWork with cross-functional teams, including Quality Assurance, Production, and MSAT, when needed. /li /ul h3REQUIREMENTS /h3 ul liAdvanced training in protein analysis with over 3 years of proven experience in Quality Control within a GMP-regulated pharmaceutical environment. /li liHands-on experience in biochemical assays, including chromatography, electrophoresis, ELISA tests, PCR, spectrophotometric methods, and skills in cell culture techniques. /li liFamiliarity with environmental monitoring in cleanroom environments or physicochemicals methods will we a plus. /li liTechnical expertise in analytical methods and the ability to supervise assays. /li liStrong knowledge of ALCOA++ principles and GMP documentation practices. /li liExperience with quality systems (OOS, deviations, CAPAs, change control). /li liProficient with the regulatory environment of the pharmaceutical industry. /li liKnowledge of analytical method development, validations, analytical transfers, and QC Laboratory management systems. /li liProactive team player with good leadership skills and the ability to work in an organized way. Quickly adapts to changes and reprioritizes tasks based on company needs. /li liFluent in Spanish with basic to intermediate English communication skills (reading/writing preferred). /li /ul /p #J-18808-Ljbffr

📌 Bioassay Quality Control Analyst (Sant Quirze del Vallès)
🏢 Leanbio
📍 Sant Quirze del Vallès