Stability & Release Analyst—HPLC/UHPLC, CGE & iCE

Pauwels Consulting; Eigenbrakel; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Our client, a prominent biotechnology organization, seeks a seasoned specialist to lead release and stability testing in their QC laboratory. You will perform and oversee analyses for products from early clinical phases to phase III, ensuring compliance with GMP and regulatory standards.

Work in a cross-functional team to manage deviations and incidents, validate results, and apply HPLC/UHPLC, CGE and iCE techniques. Adherence to HSE rules across development stages is essential.

Qualifications

• Bachelor or Master’s degree in biochemistry or analytical chemistry.
• 5+ years of experience in the biotechnology industry.
• Expertise in analytical techniques including HPLC/UHPLC, CGE, and iCE applied to proteins.
• Strong knowledge of GMP standards within a QC laboratory environment.
• Proactive, meticulous, and able to work effectively in a multicultural team.

Responsabilités

• Perform daily lab activities focused on release and stability testing for clinical products.
• Analyze and verify analytical data within a LIMS system to ensure accuracy and compliance.
• Coordinate with other analysts to organize laboratory workflows for release and stability analyses.
• Manage deviations, incidents, and result validations according to GMP standards.
• Execute analytical techniques including HPLC/UHPLC and capillary electrophoresis (CGE, iCE) for protein analysis.
• Ensure all laboratory activities adhere to HSE rules and regulatory requirements for various development phases.

Connaissances

Fluent English

Cross-functional teamwork

Formation

Bachelor or Master in Biochemistry or Analytical Chemistry

Outils

LIMS

HPLC/UHPLC

CGE/iCE

Description du poste

Our client, a prominent biotechnology organization, seeks a seasoned specialist to lead release and stability testing in their QC laboratory. You will perform and oversee analyses for products from early clinical phases to phase III, ensuring compliance with GMP and regulatory standards.

Work in a cross-functional team to manage deviations and incidents, validate results, and apply HPLC/UHPLC, CGE and iCE techniques. Adherence to HSE rules across development stages is essential.