Overview
At Leanbio, we offer end-to-end services in the field of recombinant proteins, mRNA, and pDNA.
We have over a decade of expertise in developing and manufacturing therapeutic molecules such as antibodies, Fab fragments, ADCs, enzymes, complex proteins, mRNA, and pDNA.
We are expanding our development and manufacturing capabilities with a new Good Manufacturing Practices (GMP) site in Barcelona, featuring three manufacturing areas : one for mammalian expression systems up to 2000L, another for microbial and yeast up to 1000L, and a third area for mRNA up to 50L.
The facility includes state-of-the-art development laboratories, Quality Control rooms, and a warehouse. Our commitment to excellence is evident in everything we do :
- We prioritize customer satisfaction.
- We provide cutting-edge services.
- We utilize state-of-the-art facilities.
- We offer extensive expertise in biologics.
Key Responsibilities
Perform routine and non-routine physicochemical analyses using techniques like High-Performance Liquid Chromatography (HPLC), Karl Fischer titration, Fourier Transform Infrared Spectroscopy (FTIR) / Infrared (IR), Loss on Drying (LOD), potentiometric titrations, Residue on Ignition (ROI), pH, conductivity, osmolality, Total Organic Carbon (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 data integrity principles, maintaining complete, accurate, and traceable documentation.Document all activities clearly and contemporaneously in lab notebooks or electronic systems, in compliance with internal Standard Operating Procedures (SOPs).Participate in quality system activities, such as investigating OOS / OOT results, reporting deviations, and supporting CAPAs.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.Qualifications / Requirements
This role requires strong analytical skills, attention to detail, and effective communication skills. The successful candidate will work collaboratively with cross-functional teams, including QA, production, and validation.
Benefits
We offer a dynamic work environment, opportunities for growth and professional development, and a competitive compensation package.
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