Principal Scientist, Quality Assurance

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.

For our ambitious, fast-growing team in Copenhagen, we are looking for a Principal Scientist. Working in the Quality Assurance (QA) for Quality Control (QC) team, you will take a leading role in the quality assurance of QC documentation, manufacturing activities, and batch release.

About the Department & Team
QA for QC consists of highly qualified scientists with various professional backgrounds and several years of experience within QA. In addition to the 'QA for QC' team, the quality department consists of the 'Quality Operational', 'Quality Systems', and 'QA Facility and Equipment' teams. The main responsibility of the QA for QC team is the quality assurance of QC documentation, manufacturing activities, and batch release.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim to constantly ensure that QC and manufacturing follow current standards for GMP production, i.e., EU GMP, 21 CFR, and ICH guidelines.

The department fosters open communication with a focus on a high level of professionalism. We are open-minded and highly supportive of our colleagues in the rest of AGC Biologics, as well as our international customers. The QA for QC team is characterized by positive and proactive colleagues who meet deadlines through committed and friendly collaboration.

About the Job
As a QA Principal Scientist, you will be involved in various daily operational tasks in a dynamic and challenging environment. Your main responsibility will be to support QC in analytical method validation for late-stage and commercial products, which includes:

• Close collaboration with QC, other QA teams, and QP.
• Guiding in requirements for commercial production support.
• Active involvement in major and critical laboratory investigations and deviations.
• Review and approval of analytical method validation protocols and reports.
• Change control and CAPAs.

You have…

• 6+ years in QA within QC, API, or Adjuvant manufacturing.
• A relevant degree in Pharmacy, Biotechnology, Biology, Chemistry, or a related field.
• Proficiency in deviation handling, including root cause investigations.
• Strong experience in reviewing and evaluating QC documentation.
• Proven track record of QA oversight in QC activities and providing staff guidance.
• In-depth knowledge of GMP requirements for commercial and/or late-stage clinical phase manufacturing of biological intermediates, APIs, and Cell Banks.
• Experience in QA or QC within analytical method validation.
• Familiarity with contract manufacturing and a solid understanding of business processes.
• Ability to thrive in a dynamic and challenging environment, demonstrating problem-solving skills, reliability in meeting commitments, and providing exceptional customer experiences.
• A self-motivated individual with a pragmatic attitude towards daily tasks, ensuring high quality without compromise.
• Fluent in both written and spoken English, essential for effective communication with our international customers, as English is the company language.

Are You Up for a Challenge?

• Apply with your CV.
• If we see a match, you’ll have a call with one of our recruiters to share more about what you can bring to the team.
• Are both sides still positive? Then we proceed to the assessment stage to assess key skills required for the job.
• We will be conducting interviews on an ongoing basis and will close the position once the successful candidate has been found.

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.

Location: Copenhagen Site