51244MKP - Physicochemical Quality Control Analyst (LeanbioPro)

ABOUT LEANBIO

Leanbio is a CDMO that develops and manufactures biopharmaceutical products as New biological entities and Biosimilars, located in Barcelona.

• Leanbio follows a knowledge-based strategy, applying cutting edge technological platforms and working altogether with customers.
• Leanbio is currently building a new GMP manufacturing facility with state-of-the-art technology that will cover all phases of the production process.

ROL DESCRIPTION

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 and 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.

OFFERED

Requisits : REQUERIMENTS

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