Scientist, QA for QC (12 months temporary)

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.

We are seeking a dedicated QA Scientist to join our ambitious QA for QC team in Copenhagen for a 12-month temporary position, covering a maternity leave. In this vital role, you will be instrumental in ensuring the quality of QC documentation, supporting manufacturing activities, and contributing to batch release. If you are passionate about quality and want to make a tangible impact in the biopharmaceutical industry, we encourage you to apply!

The QA Department & Team

You will be joining our QA for QC team, a group of highly qualified scientists with diverse professional backgrounds and extensive experience in Quality Assurance. The wider QA department also includes our Quality Operations, Quality System, and QA Facility and Equipment teams. Our team's core responsibility is the quality assurance of all QC-related activities. We are deeply involved in the continuous improvement of our quality systems, ensuring that all QC and manufacturing processes adhere to the latest GMP standards, including EU GMP, 21 CFR, and ICH guidelines. We pride ourselves on fostering a culture of open communication, high professionalism, and proactive collaboration. We are a positive and supportive team that meets deadlines through committed and friendly teamwork, providing excellent support to our colleagues and international customers.

Your Role & Responsibilities

As a QA Scientist, you will engage in a variety of operational tasks within a dynamic and challenging environment. Your primary focus will be supporting QC for late-stage and commercial products. Your key responsibilities will include:

• Maintaining close collaboration with the QC department, other QA teams, and the Qualified Person (QP) to ensure seamless operations and compliance.
• Providing expert guidance on quality requirements for commercial production support, ensuring all activities meet regulatory standards.
• Taking an active role in ensuring the compliance of daily QC tasks and documentation, upholding the highest standards of quality.
• Reviewing and approving critical documentation, such as stability protocols and reports, to ensure accuracy and compliance.
• Handling Change Requests, Deviations and CAPAs, including participating in root cause investigations to drive continuous improvement.

Your Profile

We are looking for a candidate who is eager to contribute their expertise and grow with us. The ideal candidate will have:

• A relevant academic degree in Pharmacy, Biotechnology, Biology, Chemistry, or a related scientific field.
• A minimum of 2 years of experience in a QA role within QC, API, or Adjuvant manufacturing.
• In-depth knowledge of GMP requirements for the manufacturing of biological intermediates, APIs, and Cell Banks for commercial and/or late-stage clinical phases.
• A self-motivated and pragmatic approach to daily tasks, committed to delivering high-quality results without compromise.
• Excellent problem-solving skills and the ability to thrive in a dynamic environment, reliably meeting commitments and supporting an exceptional customer experience.
• Experience in reviewing and evaluating QC documentation with a keen eye for detail.
• Experience with stability studies or stability program management is considered a strong advantage but not a requirement.
• Familiarity with contract manufacturing (CMO/CDMO) and a solid understanding of business processes would be beneficial but not a requirement.
• Fluency in both written and spoken English, which is essential for effective communication in our international business environment.

Your Application

Ready to join our team? We’d love to hear from you!

• Please apply with your CV. We will be reviewing applications on an ongoing basis and will close the position once the right candidate has been found.
• If your profile is a potential match, one of our recruiters will contact you for an initial call to discuss your experience and what you can bring to the team.
• If both sides remain positive, we will proceed to an assessment stage to evaluate the key skills required for this role. 

We look forward to receiving your application!
 

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.