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 an analyst to work in our brand new facilities in Sant Quirze del Vallès:
MAIN RESPONSIBILITIES:
- Perform 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.
- Carry out sampling and analysis of water systems, including:Water for Injection (WFI)
- Support environmental monitoring activities, including:surface and air sampling in classified areas.
- Ensure strict adherence to GMP and ALCOA data integrity principles, maintaining complete, accurate, and traceable documentation.
- Document all activities clearly and contemporaneously in lab notebooks, logbooks, or electronic systems (e.g., LIMS), in compliance with internal SOPs.
- Participate in quality system activities, such as investigation of OOS / OOT results reporting of deviations and support in CAPA implementation.
- Maintain and calibrate laboratory equipment, performing routine checks and informing of any malfunction or need for maintenance.
- Follow safety protocols and contribute to keeping the lab in a clean condition at all times.
- Collaborate with cross-functional teams, including QA, production, and validation, when needed.
REQUIREMENTS:
- Advanced Training in Laboratory Analysis and Control with 2-5 years of experience in Quality Control in a GMP-regulated pharmaceutical environment.
- Practical experience in physicochemical testing including HPLC, Karl Fischer, IR, Loss on Drying, potentiometric titrations, and Residue on Ignition.
- Skilled in sampling and analysis of pharmaceutical water systems (WFI, Purified Water) following USP/EP methods.
- Familiarity with environmental monitoring in cleanroom environments is an asset.
- Strong knowledge of ALCOA principles and GMP documentation practices.
- Experience with quality systems (OOS, deviations, CAPAs, change control).
- Proactive team player with good organizational skills and the ability to work independently.
- Fluent in Spanish with basic to intermediate English communication skills (reading/writing preferred).