Principal Scientist, Quality Control

Employer: AGC Biologics

Location: Copenhagen, Denmark

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you an experienced and passionate specialist in QC equipment, software, and compliance? Do you have a solid understanding of data integrity and enjoy working in a dynamic team where independence and expertise are key? If so, this position in our QC Equipment Department could be the perfect opportunity for you!

About QC & The QC Equipment Department:
The Quality Control (QC) organization is responsible for release testing of clinical and commercial batches, and validation of the analytical methods, as well as analysis of raw materials and stability programs. We are working in an international and customer oriented way to secure fast and reliable manufacturing of medicines to our customers.

QC consists of five departments: QC Bioassay, QC Chemistry, QC Microbiology, QC Support and QC Planning & Systems. The first three mentioned are major analytical areas, and the last two mentioned are support areas.

The current position is located in the QC Planning & Systems area, in the QC Equipment Department. QC Equipment consists of 12 dedicated and skilled professionals, supporting all equipment in QC. The role is based in Søborg, Denmark.

Role & Responsibilities:
You will play a pivotal role in managing the QC equipment and software (i.e. HPLC, CE, Octet, SoloVPE, qPCR, NIR, pipette robots). You will be responsible for ensuring that our equipments meet regulatory requirements and standards while actively contributing to hands-on equipment troubleshooting. This position requires a combination of technical expertise, and a deep understanding of data integrity principles.

Your Key Responsibilities:

• Equipment lifecycle management, including qualification and validation.
• Ensure compliance with cGMP regulations and ALCOA+ principles.
• Configuration of software, and collaborate with the IT department.
• Work with software and computerized QC equipment, including documentation and troubleshooting.
• Actively participate in laboratory troubleshooting
• Contribute to process optimization and the implementation of new technologies.
• Collaborate with team members and cross-functional departments to ensure efficient operations and high-quality outcomes.

Your Profile:

• A relevant scientific degree, within chemistry, biotechnology, engineering or pharmaceutical sciences.
• Documented experience with QC equipment and software, including qualification, validation, and compliance.
• Strong understanding of cGMP regulations and ALCOA+ principles.
• Practical experience with laboratory work and equipment.
• Independent, structured, and proactive in your approach to work.
• Thrive in a dynamic environment and possess excellent collaboration skills.

What We Offer:

• An exciting and challenging position in a dynamic QC Equipment Department.
• Opportunities for professional and personal development.
• A dedicated and skilled team working together to achieve common goals.
• Competitive salary and employment terms.