Scientist, QA Manufacturing Support

AGC Biologics; Søborg; On-site; DKK 480,000 - 600,000; Full time

Job summary

AGC Biologics, a global CDMO, is hiring a QA Manufacturing Support Scientist at our Søborg site in the Copenhagen area. You will provide extensive quality oversight on the production floor, review Line Approvals and Master Production Records, and manage deviations, CAPAs, and change requests in a cGMP environment.

You will participate in audits, drive continuous quality improvements, and be on-call for on-line support during critical process steps—approximately one weekend per month.

Qualifications

• MSc in Natural Science or Life Science is required.
• Experience in a cGMP environment is highly valued.

Responsibilities

• Provide extensive quality oversight on the production floor.
• Handle Line Approval, and review/approve Master Production Records (MPR) and label management for production use.
• Manage DEVs, CAPAs, and Change Requests (CRs).
• Support audits and inspections and drive continuous quality improvements.
• Be on-call on weekends (approx. 1 per month).

Education

MSc in Natural Science or Life Science

Job description

As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development to clinical and commercial production. Right now, you have the opportunity to join our Quality Assurance (QA) department as a QA Manufacturing Support Scientist! If you have an ahead-thinking mindset, are proactive, resilient, hard-working, and bring good energy to a high-performing team, this job opportunity may be a perfect match for you!

In this position, you can utilize your proactiveness, rigorous quality mindset, and experience from a cGMP environment! We offer you an opportunity for further growth by joining a dynamic team dedicated to ensuring absolute quality oversight on the shop floor. You will be a vital presence on the production floor, ensuring that Good Documentation Practices and Good Manufacturing Practices are fulfilled, performing Line Approval, managing Master Production Records (MPR) and labels for production use, and handling deviations (DEV), CAPAs, and Change Requests (CRs). We need someone eager to take on new projects and someone who is not afraid of a higher workload.

Provide extensive quality oversight on the manufacturing floor!

As a QA Manufacturing Support Scientist, your primary place is on the production floor, providing extensive Quality Oversight and ensuring seamless compliance. You will be accountable for Line Approval, ensuring that all operations meet the highest standards. Your responsibilities include reviewing and approving MPR and label management for production use, as well as managing DEVs, CAPAs, and CRs. Over time, you will also be exposed to additional responsibilities, supporting audits and inspections, capturing learnings, and implementing continuous quality improvements across our processes.

“What stands out in our team is the fact that we are all together, literally. As a team, we love to spare with each other, laugh around with others and just be present – that is what stands out in our team!” – Amelia Hrynkiewicz, QA Manufacturing Support Manager

Our team covers a duty phone, so you will be on call to ensure on-the-line support during critical process steps. You can expect to be on call approximately one weekend per month (12 hours or 24 hours depending on the production schedule).

Your experience with GMP & quality compliance is key!

As a QA Manufacturing Support Scientist, we value your scientific rigor, so bringing a MSc of Natural Science or Life Science is a requirement. Your previous experience working in a cGMP environment — preferably within the pharmaceutical industry or manufacturing — comes well into play in our environment, therefore having prior manufacturing experience is considered a strong plus. We are very keen on welcoming a new team member who is proactive, resilient, forward-thinking and ready to tackle high workloads and drive new projects forward.

You have strong communication skills, which are crucial for your interaction with internal and external stakeholders across production, manufacturing teams and other quality functions. You will utilize your skills in coordinating multi-departmental tasks and deliverables. We are looking for someone self-motivated, organized, and proactive who thrives in a collaborative team spirit alongside other proactive individuals.

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 our 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.

Location: Copenhagen Site