Senior Downstream Scientist - Biologics Process Excellence

AGC Biologics; København; On-site; DKK 700,000 - 900,000; Full time

Job summary

AGC Biologics is seeking a Senior Downstream Scientist in the MSAT department in Denmark. You will support commercial manufacturing and drive continuous improvement for complex biologics.

Lead documentation, change control, and regulatory support while coordinating across departments and providing technical leadership. You will have extensive downstream processing expertise, hands-on chromatography experience, and a track record of delivering high-quality results in a GMP environment.

Qualifications

• 6+ years pharma industry experience or 4+ years with a PhD.
• Deep knowledge of downstream processes and purification methods.
• Experience with chromatography methods development and scale-up.
• Familiarity with GMP and regulatory expectations (ICH/Q7A, 21 CFR Part 211).
• Strong data analysis and cross-team collaboration.

Responsibilities

• Lead technical support for commercial manufacturing and change control.
• Own technical documentation and ensure accuracy and completeness.
• Drive process improvements for efficiency and quality.
• Contribute to regulatory dossiers and inspections.
• Mentor and spar with other teams on technical topics.

Skills

Downstream processing

Chromatography

Data analysis

GMP knowledge

Project coordination

Training & sparring

Communication

Education

MSc in Biochemistry, Chemistry, Biology, Bioprocess

PhD in Biochemistry, Chemistry, Biology, Bioprocess

Tools

ÄKTA system

UNICORN

UF/DF systems

Minitab/JMP

Job description

AGC Biologics is seeking a Senior Downstream Scientist in the MSAT department in Denmark. You will support commercial manufacturing and drive continuous improvement for complex biologics.

Lead documentation, change control, and regulatory support while coordinating across departments and providing technical leadership. You will have extensive downstream processing expertise, hands-on chromatography experience, and a track record of delivering high-quality results in a GMP environment.