Manufacturing Readiness Scientist – Biologics Ops

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

Job summary

AGC Biologics A/S is seeking a Scientist in Manufacturing Operational Support to help ensure GMP manufacturing readiness. You will collaborate with Manufacturing, Engineering, Quality, and Supply Chain to translate production needs into practical actions, support short‑term planning, and resolve operational challenges in a fast‑paced biologics environment.

From the Søborg site, you will create and maintain GMP documentation, participate in investigations and CAPAs, and help implement new

Qualifications

• Degree in biotechnology, biochemistry, chemical engineering, life sciences, pharmacy, or related field.
• Experience in biologics API manufacturing or GMP‑regulated production.
• Experience supporting manufacturing operations, planning, technical operations, process support, or logistics.

Responsibilities

• Support daily and short-term GMP manufacturing readiness in a biologics production environment.
• Monitor readiness of materials, equipment, documentation, and resources required for planned activities.
• Identify risks, constraints, and dependencies that may affect production and drive 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.
• Assist Manufacturing in resolving day‑to‑day technical and operational challenges while ensuring GMP compliance.
• Create, review, and update GMP documentation, including procedures, work instructions, risk assessments, and production‑support documentation.
• Support implementing new processes, equipment, systems, or ways of working within Manufacturing Operational Support.
• Contribute to performance monitoring, trend analysis, and identification of improvement opportunities related to production readiness and efficiency.
• Help build clear, robust, and effective ways of working in a growing operational‑support organization.

Education

Bachelor’s or Master’s degree in biotechnology, biochemistry, chemical engineering, life sciences, pharmacy, or related discipline

Job description

AGC Biologics A/S is seeking a Scientist in Manufacturing Operational Support to help ensure GMP manufacturing readiness. You will collaborate with Manufacturing, Engineering, Quality, and Supply Chain to translate production needs into practical actions, support short‑term planning, and resolve operational challenges in a fast‑paced biologics environment.

From the Søborg site, you will create and maintain GMP documentation, participate in investigations and CAPAs, and help implement new