P Leanbio 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 p Leanbio 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 p The 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: /p ulli Prioritizing customer satisfaction. /lili Providing cutting-edge end-to-end services. /lili Utilizing state-of-the-art facilities. /lili Offering extensive expertise in biologics. /li /ul p We are looking for a new person to join the QC as a Bioassay analyst to work in our brand new facilities in Sant Quirze del Vallès: /p pb MAIN RESPONSIBILITIES: /b /p ulli Perform cell proliferation methods and others bioassays to verify the potency of biotechnology products, according to to USP, EP, and internal methodologies. /lili Cell bank production, caracterization and release management. /lili Maintain detailed and contemporaneous records in laboratory notebooks, logbooks, or electronic systems (LIMS). /lili Participate in quality system activities including investigation of OOS/OOT microbiological results, deviation reporting, and support in CAPA implementation. /lili Maintain laboratory equipment calibration and functionality and promptly report any malfunctions or maintenance needs. /lili Follow all biosafety and safety protocols contributing to maintaining a clean, organized, and compliant laboratory environment. /lili Collaborate effectively with QA, production, validation, and other cross-functional teams to support quality assurance and compliance. /li /ul pb REQUIREMENTS: /b /p ulli Advanced training in bioassays analysis with 2 to 5 years of proven experience in Quality Control within a GMP-regulated pharmaceutical environment. /lili Practical expertise in bioassays used in biotechnology, including cell proliferation assay, following USP and EP methods. /lili Skilled in cell culture. Strong knowledge of ALCOA++ data integrity principles and GMP documentation practices. /lili Experienced in managing quality systems including Out of Specification (OOS) investigations, deviation reporting, CAPA implementation, and change control. /lili Proactive team player with strong organizational skills and the ability to work independently while ensuring strict compliance with regulatory requirements. /lili Fluent in Spanish with basic to intermediate English communication skills (reading and writing preferred). /li /ul