Scientist, QA Manufacturing Support

AGC Biologics, Inc.; København; On-site; DKK 450,000 - 650,000; Full time

Job summary

AGC Biologics is seeking a QA Manufacturing Support Scientist to provide extensive quality oversight on the production floor, ensuring GMP compliance and accurate documentation.

You will review and approve MPRs and labels, manage deviations, CAPAs, and change requests, and support audits. The role is on-site at the Søborg site in Denmark.

A MSc in Life Science or Natural Science is required, and prior cGMP manufacturing experience is preferred; on-call weekend coverage is part of the duties.

Qualifications

• MSc in Life Science or Natural Science required.
• Experience in a cGMP environment preferred, ideally in pharma/manufacturing.

Responsibilities

• Perform Line Approval and manage Master Production Records (MPR) and labels for production use.
• Handle DEVs, CAPAs, and Change Requests (CRs).
• Support audits and inspections and implement continuous quality improvements.
• Provide extensive quality oversight on the production floor.

Skills

GMP compliance

Quality oversight

Line Approval

MPR review

Label management

Deviation management

CAPA management

Change requests

On-call responsibility

Education

MSc in Life Science or Natural 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‑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. AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and 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!