Chemistry Project Coordinator

4 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

About Our Team

Our QC Chemistry department 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.

Job Description

In this role, you will play a central part in ensuring QC Chemistry delivers on its commitments. Your responsibilities will include:

Key Tasks:

  • Representing Our Team: You will represent our team in customer project teams, core project teams, and internal QC groups.

  • Leading Cross-Functional Teams: You will lead cross-functional QC analytical project teams to drive progress and meet milestones.

  • Coordinating Method Validations: You will oversee the coordination of method validations, transfers, and batch release schedules.

  • Writing and Reviewing Documentation: You will write, review, and approve GMP documentation, including CAPAs, deviations, CoAs, and change control cases.

  • Advising Management: You will advise management on QC-related matters and contribute to organizational optimization and process improvement.

  • Participating in Regulatory Inspections: You will participate in regulatory inspections (e.g., DMA, FDA) and customer audits.

Your Qualifications

The ideal candidate will have 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.


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