QC Coordinator

4 days ago

Copenhagen, Copenhagen, Denmark AGC Biologics Full time
QC Coordinator (Analytical Project Manager), QC Chemistry

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.

The Opportunity

Are you passionate about coordinating analytical activities and driving projects in a dynamic, international environment? Do you enjoy working across teams to support clinical and commercial manufacturing? If so, we have an exciting opportunity for you to join QC Chemistry as a QC Coordinator (Analytical Project Manager). In this role, you will serve as a key link between our QC teams, external customers, and internal stakeholders, ensuring analytical activities are executed efficiently, on time, and with the highest quality.

The QC Chemistry Department

QC Chemistry is a vital part of the Quality Control (QC) organization at AGC Biologics. We support the production of biopharmaceuticals by performing analytical testing and validating methods across all phases – from clinical (Phase I–III) to commercial manufacturing. Our team collaborates closely across QC, with other departments within AGC Biologics, and with external customers and vendors.

As QC Coordinator (Analytical Project Manager), you will play a central role in ensuring QC Chemistry delivers on its commitments. Key responsibilities include:

  • Project Coordination: Represent QC Chemistry in customer project teams, core project teams, and internal QC groups. Act as the single point of contact for QC-related matters.

  • Project Leadership: Lead cross-functional QC analytical project teams to drive progress and meet milestones.

  • Analytical Expertise: Oversee the coordination of method validations, transfers, and batch release schedules. Collaborate with QC subject matter experts to ensure timely execution. Support review of analytical data for batch release, stability studies and in-process samples.

  • Documentation and Compliance: Write, review, and approve GMP documentation, including CAPAs, deviations, CoAs, and change control cases.

  • Strategic Input: Advise management on QC-related matters and contribute to organizational optimization and process improvement. Establish and update Specifications. Key owner of project Drug Substance and Drug Product Specifications.

  • Regulatory Support: Participate in regulatory inspections (e.g., DMA, FDA) and customer audits.

  • Relationship Building: Foster strong communication and collaboration across departments, with customers, and with external partners.

Your Profile

The ideal candidate will bring a mix of technical expertise, project coordination skills, and a proactive mindset. Key qualifications and skills include:

  • Education: MSc in Chemistry, Biochemistry, or a related field with 2–6 years of relevant experience; or PhD with 3 years of relevant experience.

  • Technical Expertise: Solid experience with analytical chemistry techniques (e.g., HPLC, CE, iCE).

  • Project Management: Ability to manage multiple projects, oversee milestones, and drive coordination across stakeholders.

  • GMP Knowledge: Experience working in cGMP settings under EU and US regulatory guidelines.

  • Communication Skills: Strong interpersonal skills to build relationships and effectively communicate with both internal and external stakeholders.

  • Fluency in English: Written and spoken. Interest in learning Danish is an advantage.

Why Join AGC Biologics?

At AGC Biologics, you'll be part of a collaborative, purpose-driven organization that values teamwork, personal development, and innovation. We offer:

  • An international, dynamic working environment

  • Strong collaborative and teamwork culture

  • Opportunities to grow and shape your role in a fast-moving company

  • A chance to contribute to life-changing therapies for patients worldwide

Application
Submit your application as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

AGC Biologics is an equal opportunity employer.

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