Principal Scientist, Quality Control

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.

Your Application:
We look forward to hearing from you! Please submit your application as soon as possible! We treat the applications as we receive and conduct interviews with qualified candidates. When the right candidates are found, the add will close. If you have any questions about the position, feel free to contact Jesper Fuglsang Luxhøi at [email protected].

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.