Senior Scientist, QC Stability

Do you want to apply your stability expertise in a role where science, customer collaboration, and real impact go hand in hand? In our QC Stability team, we support a diverse portfolio of external customers by designing and delivering high-quality stability programs tailored to their products and regulatory needs. As a Senior Scientist, you will act as a scientific expert/SME and trusted partner, helping customers navigate stability strategies across the product lifecycle. If you have significant stability knowledge and experience, you could be exactly the new colleague we are looking for!

Join a QC team driven by team spirit!

You will be part of QC Support where you will join a team of highly dedicated scientists and technicians. QC Support consists of five departments: QC Raw materials, QC Samples Service, Equipment, LIMS and QC Stability. You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo and Reference Material. Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA.

"This is a great opportunity for someone who enjoys a good team spirit and values team sparring and supporting each other! You will join a collaborative and supportive QC team where knowledge sharing, accountability and continuous improvement are part of how we work every day. Our team values curiosity, ownership, and a pragmatic approach to solving complex challenges – both internally and in our interactions with customer." ​- Nicolaj Larsen, Manager of QC Stability.

You will become a trusted and key stability partner!

As a Senior Scientist in Stability, you will play a key role in defining and delivering stability studies for a diverse portfolio of external customers. You will act as a scientific expert and trusted partner, ensuring high-quality, compliant, and timely stability programs tailored to customer and regulatory requirements.

Working at the interface between science and customer collaboration, you will take ownership of stability strategies across multiple projects and support customers throughout the product lifecycle. You will be trusted with a variety of responsibilities:

• Leading the design, planning and execution of customer-specific stability programs for drug substance (DS) and drug product (DP)
• Acting as a scientific advisor to customers on stability strategies, study design, and regulatory expectations.  
• Writing and reviewing stability protocols, reports and quality documentation (e.g. CRs, deviations, CAPAs)
• Managing customer interactions, including meetings, scientific discussions and expectation alignment
• Ensuring timely delivery of stability data and reports in line with agreed timelines and quality standards
• Overseeing testing at external laboratories
• Ensuring cGMP compliance with relevant guidelines (ICH, EU, FDA) across all activities
• Represent stability during audits and inspections and support response to health authority queries (e.g. FDA, EMA)
• Drive continuous improvement initiatives within stability processes
• Mentoring junior scientists and contributing to a strong scientific team environment

Your stability experience will come into play from day one!

We are looking for a scientifically strong and customer-oriented professional who thrives in a dynamic, project-driven environment. A specific educational level is not required, we are value your experience within stability studies in a GMP-regulated environment, and the more the better, so 5-8 years as a minimum. Your strong knowledge of stability requirements for DS/DP and relevant guidelines (ICH, EU, FDA) will quickly come into play. It would be an advantage if you have experience working in a CRO, CDMO or other customer-facing environments as well as having the ability to manage multiple projects and stakeholders simultaneously and demonstrated experience in driving continuous improvement and/or productivity programs. On the personal characteristics, we appreciate a proactive and structured approach with strong stakeholder management skills and excellent communication skills in English, both written and spoken.
 

Your application & our interview process

Send your application no later than May 31. We treat the applications as we receive them and conduct interviews with qualified applicants during the first weeks of June, aiming for a start date August 1. We look forward to hearing from you!
 

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.  

Global contract development and manufacturing organization (CDMO) for biopharmaceuticals and cell/gene therapies. Based in Seattle, WA.

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