Bioassay Quality Control Analyst

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

Location: Sant Quirze del Vallès, Catalonia, ES

Posted Date: 9/7/2025