Biological Research Scientist

The successful candidate will join 3Pbiovian, a leading biotechnology company in Navarra, Spain, as a Biological Research Scientist reporting to the Head of Biological Laboratory in collaboration with other QC technicians and analysts.

• Lead small teams in the development of analytical methods, specific for both client projects and for platform establishment, to ensure the biomolecules manufactured at 3Pbiovian conform to GMP/regulatory expected criteria for quality attributes.
• Manage the Biological laboratory, including development, laboratory supervision, document review and validation of microbiological (Bioburden, endotoxins, analysis of water for injection, environmental monitoring) analytical methods (SDS-PAGE, Western Blot, Determination of total protein concentration, ELISA, qPCR, control of water plant for injectables, etc).
• Write protocols and validation reports, stability reports, and reports of analytical method transfers.
• Elaborate and revise Standard Operating Procedure (SOPs) and manage corrective actions, deviations, change controls, release of materials, out-of-specification results, risk management, etc.
• Experience in performing analysis of proteins with standard biochemical and biophysical techniques.
• Familiarity with recombinant proteins, mAbs, Biosimilar, ADCs and Pharmaceutical regulatory guidelines.

• Degree in Biology, Biochemistry, Pharmacy or Chemistry.
• Postgraduate training.
• Experience within regulated environments for performance of quality control.
• Development, transfers and validation of Analytical methods.
• Knowledge of molecular biology techniques specific to the characterization of proteins and microbiology techniques.
• Fluent in English.
• Willing to relocate to Northern Spain.