Downstream Process Support Scientist - On-Call

AGC Biologics, Inc.; København; On-site; DKK 480,000 - 640,000; Full time

Job summary

AGC Biologics, Inc. is seeking a Downstream Scientist to support production in our Manufacturing Product Support team.

The role focuses on owning batch documentation, reviewing Master Production Records, and enabling timely deviations with root-cause investigations. The ideal candidate has a BSc or MSc in life sciences and at least two years of experience in a cGMP manufacturing setting, with strong communication and troubleshooting skills.

Qualifications

• BSc or MSc in natural or life sciences preferred.
• 2+ years of experience in a manufacturing team under cGMP, preferably in the pharmaceutical industry.
• Experience writing, reviewing, and approving GMP documentation; familiarity with deviations and CAPAs.
• Experience with single-use technologies and aseptic processing is a plus.

Responsibilities

• Own batch documentation, review, and deviation handling.
• Provide support to production and ensure timely, error-free execution.
• Create and review the Master Production Record.
• On-call/shopfloor support for critical process steps (approx. 24 hours, three times a month).
• Lead troubleshooting efforts and coordinate multi-departmental tasks (Process Transfer, Validation, QA, QC).
• Participate in audits and inspections and capture learnings for continuous improvement.

Skills

Communication skills

Team collaboration

Problem-solving

Attention to detail

Project coordination

Education

BSc or MSc in natural or life sciences

Job description

AGC Biologics, Inc. is seeking a Downstream Scientist to support production in our Manufacturing Product Support team.

The role focuses on owning batch documentation, reviewing Master Production Records, and enabling timely deviations with root-cause investigations. The ideal candidate has a BSc or MSc in life sciences and at least two years of experience in a cGMP manufacturing setting, with strong communication and troubleshooting skills.