Biopharmaceutical Quality Control Lead

5 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

About the Role

We are looking for a highly skilled Analytical Project Manager to join our QC Chemistry department. In this role, you will serve as a key link between our QC teams, external customers, and internal stakeholders.

Key Responsibilities:

  • Project Coordination: Represent our team in customer project teams, core project teams, and internal QC groups.

  • 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.

  • 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.

  • 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.



  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We are seeking a highly skilled Validation and Quality Control Professional to join our team as a maternity cover for 1.5 years.As a key member of the QC Chemistry department,...


  • Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

    Your New RoleAs our Senior Quality Control Scientist, you will:Be the technical lead and subject matter expert for Quality Control activities with focus on drug-device combination productsCollaborate within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory AffairsReview and approve protocols, reports, and...


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Bioassay Manager to join our team in Copenhagen, Denmark.As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and integrity of our biopharmaceutical products. Your expertise in bioassay testing and compliance with regulatory requirements will be crucial...


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    Job DescriptionAGC Inc. is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and...


  • Copenhagen, Copenhagen, Denmark Blackfield Associates Full time

    Job DescriptionBlackfield Associates is seeking a skilled Project Engineer to support project deliverables for a large-scale biopharmaceutical construction project in Copenhagen, Denmark.The ideal candidate will have experience overseeing and coordinating electrical & instrumentation (E&I) and building management system (BMS) contractor activities to ensure...


  • Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

    About the PositionWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team.As our Senior Quality Control Scientist, you will be responsible for technical leadership and subject matter expertise in Quality Control activities with a focus on drug-device combination products.You will work closely with...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    About AGC BiologicsWe are 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...


  • Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full time

    Are you passionate about the development of new drug-device combination products? Do you have experience within the development of medical devices for drug delivery? If so, now is your chance to join Ascendis Pharma as our new Senior Design Control Specialist. Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany,...


  • Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

    Overview of CMC BiologicsH. Lundbeck A/S is a global pharmaceutical company focused on the development and commercialization of innovative treatments for brain disorders.We are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics team, which supports the development and production of new biologics drug candidates for diseases...


  • Copenhagen, Copenhagen, Denmark NKT AS Full time

    NKT A/S is a global leader in the production of high-voltage power cables, and we are seeking a highly skilled High Voltage Cable Quality Control Expert to join our team. In this role, you will be responsible for ensuring the highest quality standards are met in the development and manufacturing of our high-voltage cable solutions.Your expertise in quality...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. As a Quality Assurance and Control Professional, you will be responsible for ensuring the highest standard of quality in our products. You will work closely with the production team to ensure that...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    We are a company driven by six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. Our commitment to these values serves as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.As a scientist at AGC Biologics, you will have the opportunity to work on various projects...


  • Copenhagen, Copenhagen, Denmark Better Collective GmbH Full time

    Better Collective is a dynamic and innovative international company seeking a highly motivated and experienced Senior Financial Controller to lead the financial function to the next level.This role offers the opportunity to develop and maintain a robust financial controlling framework, ensuring accurate and timely financial reporting.As a key member of the...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    AGC Biologics is a leading Contract Development and Manufacturing Organization (CDMO) within the biotech industry, specializing in developing biopharmaceutical production processes and GMP production of biopharmaceutical proteins for clinical studies and commercial markets.We are seeking a skilled Manufacturing Technician to join our production team, which...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We are looking for a highly skilled CMC Technical Integration Lead to join our team in Copenhagen. As a key member of our CMC Management Team, you will be responsible for leading the integration of new/specific required analytical/process strategies into CMC Development Paths deviating from our CMC platform.You will work closely with our CMC PM team to...


  • Copenhagen, Copenhagen, Denmark Klépierre Upgraded Full time

    Job DescriptionAbout Us: Klépierre Upgraded is a leading shopping center company in Scandinavia, committed to excellence and innovation.Position Overview: We are seeking a dedicated Financial Controller to oversee financial reporting processes, focusing on management activities and group investments/capital expenditures (Capex). This role ensures accurate...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    Job DescriptionAs a technician in our production team, you will be involved in planning and executing different steps in the production process, including protein purification and equipment setup. Your key responsibilities will include:Setting up and operating equipment such as SUM systems, columns, filters, Äkta Ready systemsExecuting processes such as...


  • Copenhagen, Copenhagen, Denmark Pandora AS Full time

    Pandora A/S is seeking a Quality Assurance Lead to join our team in Copenhagen V, DK. As a key member of our quality engineering and assurance teams, you will play a crucial role in ensuring the quality of our e-commerce platforms, retail technology, and order management systems.The ideal candidate will have extensive experience in quality engineering and...


  • Copenhagen, Copenhagen, Denmark Klépierre Upgraded Full time

    About Us: Steen & Strøm is a leading shopping center company in Scandinavia, committed to excellence and innovation. We value care, commitment, exploration, and development in all our endeavors. Position Overview: We are seeking a dedicated Financial Controller to oversee financial reporting processes, with a specific focus on our management activities...


  • Copenhagen, Copenhagen, Denmark Klépierre Upgraded Full time

    About Us: Steen & Strøm is a leading shopping center company in Scandinavia, committed to excellence and innovation. We value care, commitment, exploration, and development in all our endeavors.Position Overview: We are seeking a dedicated Financial Controller to oversee financial reporting processes, with a specific focus on our management activities and...