Scientist, Manufacturing Readiness & Operations

AGC Biologics, Inc.; København; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

AGC Biologics, Inc. in Copenhagen is seeking a Scientist, Manufacturing Operational Support to help ensure GMP manufacturing readiness.

You will coordinate materials, equipment, and documentation, work with Manufacturing, Engineering, Quality, and Supply Chain, and support day-to-day production readiness in a fast-paced biologics environment. This hands-on role emphasizes problem solving, investigations, CAPAs, and continuous improvement, with a focus on handling deviations, change controls, and

Qualifications

• Bachelor's or Master's degree in biotechnology, biochemistry, chemical engineering, life sciences, or pharmacy.
• Experience in biologics API manufacturing or GMP-regulated production.
• Strong communication and cross-functional collaboration.
• English proficiency; Danish is a plus.

Responsibilities

• Support daily and short-term manufacturing readiness activities in a GMP-regulated biologics production environment.
• Monitor readiness of materials, equipment, documentation, and operational resources required for planned manufacturing activities.
• Identify potential risks, constraints, and dependencies that may affect production execution, and drive or support mitigation actions.
• Support coordination and follow-up of operational issues, deviations, equipment-related challenges, and production escalations.
• Participate in root-cause analyses, investigations, CAPAs, change controls, and continuous-improvement initiatives.

Skills

English proficiency

Cross-functional collaboration

GMP knowledge

Problem solving

Documentation

Education

Biotech/Biochem/Chem Eng degree

Job description

AGC Biologics, Inc. in Copenhagen is seeking a Scientist, Manufacturing Operational Support to help ensure GMP manufacturing readiness.

You will coordinate materials, equipment, and documentation, work with Manufacturing, Engineering, Quality, and Supply Chain, and support day-to-day production readiness in a fast-paced biologics environment. This hands-on role emphasizes problem solving, investigations, CAPAs, and continuous improvement, with a focus on handling deviations, change controls, and