Scientist, Manufacturing Operational Support

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

About the Role At AGC Biologics, successful manufacturing starts well before production begins. It depends on having the right plans, materials, equipment, documentation, and coordination in place to enable safe, compliant, and reliable execution. As a Scientist in Manufacturing Operational Support, you will play a key role in preparing and supporting daily GMP manufacturing operations. Working closely with Manufacturing, Engineering, Supply Chain, Quality, and other support functions, you will help ensure that production is ready to execute according to plan and that operational challenges are resolved effectively. This is a hands‑on role for someone who thrives in a dynamic manufacturing environment, enjoys creating structure, and wants to make a direct impact on the delivery of life‑changing biologics to patients worldwide.

Where Scientific Expertise Supports Operational Readiness

As part of the Manufacturing Operational Support team, you will act as a key link between shift‑based manufacturing and the wider support organization. Your primary focus will be to ensure that manufacturing activities are operationally ready. This includes supporting short‑term production planning, coordinating materials and equipment readiness, maintaining oversight of operational dependencies, and helping address issues that could affect production execution. You will work closely with Manufacturing Technicians, Scientists, Team Leads, and cross‑functional stakeholders to translate production needs into practical, timely actions. When challenges arise, you will contribute to investigations, escalation handling, troubleshooting, and implementation of sustainable solutions.

Key Responsibilities

In this role, you will:

• 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 the 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 as relevant to the role.
• Assist Manufacturing in resolving day‑to‑day technical and operational challenges while ensuring compliance with GMP requirements and site procedures.
• Create, review, and update GMP documentation, including procedures, work instructions, risk assessments, and production‑support documentation.
• Support implementation of 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 operational efficiency.
• Help build clear, robust, and effective ways of working in a growing and evolving operational‑support organization.

A Role With Broad Operational Impact

You will join a team that is central to the performance of Manufacturing. Your work will directly influence whether production can start on time, run as planned, and recover quickly when unexpected challenges occur. The role requires a strong overview of complex activities, combined with the ability to manage details, priorities, and stakeholders effectively. You will be expected to take ownership, communicate clearly, and remain solution‑oriented in a fast‑paced environment. As the organization continues to mature, you will also have the opportunity to help shape processes, strengthen cross‑functional collaboration, and contribute to a culture of accountability and continuous improvement.

What Will Help You Succeed

You are structured, proactive, and comfortable working at the interface between scientific, technical, and operational activities. You enjoy collaborating across functions and can balance GMP compliance with the need for practical, timely execution. You are able to independently drive tasks forward while knowing when to involve the right stakeholders. You remain calm and focused when priorities shift, and you approach challenges with curiosity, sound judgment, and a commitment to sustainable solutions.

You Likely Have

A bachelor’s or master’s degree in biotechnology, biochemistry, chemical engineering, life sciences, pharmacy, or a related discipline. Relevant experience from biologics API manufacturing, GMP‑regulated production, or another highly regulated manufacturing environment. Experience supporting manufacturing operations, production planning, technical operations, process support, logistics, or similar functions. Good understanding of GMP principles, quality systems, and documentation requirements. Experience with deviations, investigations, CAPAs, change controls, and/or risk assessments is an advantage. Understanding of manufacturing equipment, production processes, and material flows. Experience from a multi‑shift production environment, CDMO, or complex manufacturing setup is an advantage. Strong communication and stakeholder‑management skills in a cross‑functional and international environment. Professional proficiency in English; Danish is an advantage.

Personal Qualifications

We are looking for someone who:

• Takes ownership and follows tasks through to completion.
• Creates structure and maintains an overview in a complex operational environment.
• Collaborates effectively with colleagues across functions and levels of the organization.
• Is comfortable being close to day‑to‑day manufacturing operations.
• Can prioritize effectively and make sound decisions when plans change.
• Has a practical, service‑minded, and improvement‑oriented approach.
• Demonstrates high integrity and a strong commitment to quality, safety, and compliance.

A Culture Built on Collaboration and Accountability

At AGC Biologics, we believe that strong performance starts with strong teams. You will join an international and collaborative environment where Manufacturing, Quality, Engineering, and support functions work closely together to deliver for our customers and, ultimately, for patients. We value a proactive mindset, clear communication, structured execution, and people who take pride in making a meaningful difference.

Location

We can only consider candidates currently based in Denmark or the Greater Malmö area, as relocation support is not available for this position.

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial‑based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across the global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and our teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life‑changing drug products. If you’re motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!