Downstream Scientist, Manufacturing Support – cGMP Ops

AGC Biologics; Søborg; On-site; DKK 600,000 - 900,000; Full time

Job summary

AGC Biologics in Søborg (Copenhagen area) is seeking a Downstream Scientist to support production by reviewing Master Production Records and guiding on-line batch execution to ensure timely, error-free manufacture.

The role requires a BSc/MSc in life sciences and 2+ years’ cGMP experience in pharmaceutical manufacturing, with GMP documentation, deviations, CAPAs, and single-use/aseptic processing familiarity. Strong cross-functional collaboration is essential.

Qualifications

• BSc or MSc in life sciences is preferred.
• 2+ years in a manufacturing team operating under cGMP in the pharmaceutical industry.
• Experience writing, reviewing and approving GMP documentation, including deviations and CAPAs.

Responsibilities

• Support production by creating and reviewing Master Production Records.
• Facilitate solutions when break-downs occur during batch execution.
• Ensure timely deviation closure and root cause investigations.
• Participate in audits, customer meetings, and implementing process improvements.

Skills

GMP knowledge

cGMP manufacturing

Troubleshooting

Communication

Cross-functional teamwork

Education

BSc/MSc in life sciences

Tools

Single-use systems

Aseptic processing

Job description

AGC Biologics in Søborg (Copenhagen area) is seeking a Downstream Scientist to support production by reviewing Master Production Records and guiding on-line batch execution to ensure timely, error-free manufacture.

The role requires a BSc/MSc in life sciences and 2+ years’ cGMP experience in pharmaceutical manufacturing, with GMP documentation, deviations, CAPAs, and single-use/aseptic processing familiarity. Strong cross-functional collaboration is essential.