Senior Downstream Scientist, Manufacturing Support (cGMP)

AGC Biologics; København; Vor Ort; DKK 700.000 - 900.000; Vollzeit

Zusammenfassung

AGC Biologics is seeking a Senior Downstream Scientist for the Manufacturing Product Support team in Denmark. The role focuses on supporting production activities, ensuring compliance with quality requirements, and maintaining thorough GMP documentation.

The candidate brings a strong background in downstream processes, cGMP operations, and collaboration across Process Transfer, Process Validation, Engineering, QA, and QC. A BSc/MSc in life sciences is preferred.

Qualifikationen

• A BSc or MSc in natural or life sciences is preferred.
• At least four years of experience in a manufacturing team operating under cGMP.
• Experience with GMP documentation and deviation handling is valued.

Aufgaben

• Create and review Master Production Records and batch documentation.
• Facilitate solutions when issues arise during batch execution.
• Ensure timely deviation closure and root-cause investigations.
• Participate in audits, inspections, and continuous process improvement initiatives.

Kenntnisse

GMP experience

Downstream processing

cGMP documentation

Cross-functional collaboration

Ausbildung

BSc/MSc in life sciences

Tools

Single-use technologies

Jobbeschreibung

AGC Biologics is seeking a Senior Downstream Scientist for the Manufacturing Product Support team in Denmark. The role focuses on supporting production activities, ensuring compliance with quality requirements, and maintaining thorough GMP documentation.

The candidate brings a strong background in downstream processes, cGMP operations, and collaboration across Process Transfer, Process Validation, Engineering, QA, and QC. A BSc/MSc in life sciences is preferred.