Scientist, Quality Control

at  AGC Biologics

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.
AGC Biologics is looking for a QC Scientist to join our QC Samples and Service team
The position
You will be a part of the QC Samples and Service team, which is part of the Quality Control (QC) department at AGC Biologics and consists of approximately 155 employees divided into different support and testing teams. You will be part of QC Support, where you will join an area of highly dedicated scientists and technicians. QC Support consists of three teams: QC Raw Materials, QC Stability, and QC Samples & Service.
Your working day is characterized by ongoing collaborations with internal stakeholders, project managers, management, QA, and your team QC Samples ad Service.
For this specific position, there will be a focus on the writing of compliance documents such as SOPs, TEQs, Change Requests, Deviations, and CAPAs, but also plenty of opportunity to take the lead and drive implementation of data overviews, tools to ensure equipment maintenance, and keep track of KPIs together with the team.
Our AGC Biologics Copenhagen site will during 2024 open a new manufacturing facility, where all the QC departments will be located. The new QC laboratories and office building will be state-of-the-art, and you will be able to be part of the implementation process for QC Samples and Services by ensuring the establishment of new structures and flows in our procedures and processes, LEAN thinking, continuous improvement, data collection and tools for presentations.

Your primary tasks and responsibilities involve:

• Writing and reviewing SOPs, TEQs, Change Requests, Deviations, and CAPA documents within deadlines
• Engaging our compliance tasks in the team on your own or in collaboration with your team
• Drive and be part of the implementation of data-related overview tools to support the daily tasks of the team and KPI achievements.
• Challenging the status quo and drive a continuous improvement culture
• Ensuring cGMP compliance with relevant guidelines (EU, FDA)

About the Samples & service team
QC Samples and Service is a support team and consists of 6 dedicated technicians. The primary daily delivery in the team is to support our testing teams with samples for testing to ensure and support batch release on time. The team plays an important role as part of the sample flow from our manufacturing department to laboratory tests in QC.
We have a high team spirit where we strive to help and support each other across the teams to reach our goals and support a high level of collaboration and possibilities for personal development.
Professional and personal Qualifications
The ideal candidate holds an MSc in Biochemistry, Pharmaceutical Science, or other relevant area.
It is an advantage if you have an interest in data handling and have ideas to make complex data simple to understand, and to make it visual.
Experience of working in GMP-regulated areas is an advantage but not a requirement.
You have great dedication and enjoy team spirit, as we believe in teamwork to reach our goals. The position requires an open mind for different compliance tasks, collaboration with stakeholders in the organization, a can-do attitude, and respect for the people around you. You meet and greet people with a smile, and look for solutions with an open and communicative approach, where you listen to understand and have a curiosity and pragmatic way of handling things. As a compliance Scientist, the tasks will vary and no day is the same.
Furthermore, you thrive in a challenging and dynamic environment and enjoy a rapid pace of work where you bring in solutions and optimization, and eager to learn new tasks.
You bring a positive attitude and a good sense of humor to the already existing team spirit.
Interested in joining our team?
We look forward to hearing from you.
Send your application as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified applicants before the deadline. If you need further information about the position, please feel free to contact Joy Melchert, Manager of QC Samples and Service at +45 27602135
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
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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

• Writing and reviewing SOPs, TEQs, Change Requests, Deviations, and CAPA documents within deadlines
• Engaging our compliance tasks in the team on your own or in collaboration with your team
• Drive and be part of the implementation of data-related overview tools to support the daily tasks of the team and KPI achievements.
• Challenging the status quo and drive a continuous improvement culture
• Ensuring cGMP compliance with relevant guidelines (EU, FDA