Biologics Quality Assurance Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

Lundbeck A/S, H is seeking a highly skilled Biologics Quality Assurance Specialist to join our international CMC Biologics team. As our new specialist, you will be responsible for ensuring the quality of Lundbeck's development biological drugs from Phase I to Phase III before transfer to the commercial manufacturing team.

You will work closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, such as sampling plans, Certificate of Analysis, stability studies, method validation, etc. You will also review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.

This position requires excellent knowledge of GDP/GMP guidelines, the United States Pharmacopoeia, and the European Pharmacopoeia. Additionally, you should have a good understanding of methods used to test biological molecules, such as SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA.

The ideal candidate will have a strong background in pharmaceutical sciences, biochemistry, analytical chemistry, protein chemistry, biology, or equal. They should also possess advanced English verbal and written communication skills.



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

    Company OverviewC. H. Lundbeck A/S is a global pharmaceutical company that has been active in the production of drugs for more than 70 years. Our main goal is to develop and commercialize treatments for brain diseases.Job DescriptionWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team. As a member of...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    About AGC BiologicsAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) specializing in the development and manufacture of biopharmaceutical products.We focus on delivering high-quality solutions for clinical and commercial markets.Our mission is to improve patient outcomes around the world by working...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    At AGC Biologics, we are a global 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. Our team is tailored to each client's needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation, and...


  • Copenhagen, Copenhagen, Denmark PRS Full time

    Company OverviewPRS Copenhagen Municipality, a leading provider of construction services in the Capital Region of Denmark, seeks an experienced Quality Assurance Specialist to join their Data Centre Team.


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    About AGC IncAGC Inc is a renowned global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) dedicated to delivering exceptional services as we collaborate closely with our clients and partners. Our primary objective is to bring hope to life for patients worldwide by developing and manufacturing innovative biopharmaceuticals.Company...


  • Copenhagen, Copenhagen, Denmark AGC Inc Full time

    Regulatory Quality Assurance ManagerWe are seeking an experienced Regulatory Quality Assurance Manager to join our team in QC General Analytics. The successful candidate will have a strong background in regulatory affairs and experience in quality assurance, method validations, and regulatory compliance.The ideal candidate will be responsible for ensuring...


  • Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full time

    About the RoleWe are seeking a skilled and innovative Quality Assurance Innovation Specialist to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will have the opportunity to establish and develop a new role that aligns with our strategic objectives.In this position, you will be responsible for overseeing and...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    We are looking for a talented Scientist to join our QA or Manufacturing team at AGC Biologics. As a key contributor, you will be responsible for ensuring the highest standards of quality in our production processes.Key areas of focus include:Microbial ProductionMammalian ProductionSolution PreparationManufacturing SupportFacility & EquipmentMaterial...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Novo Nordisk A/S is a dynamic and innovative company that prioritizes quality and professionalism.Job DescriptionWe are seeking an experienced Quality Assurance Specialist to join our team in Global Contract Manufacturing Drug Substance (GCM DS). As a key member of our QA team, you will be responsible for ensuring the highest standards of quality and...


  • Copenhagen, Copenhagen, Denmark Wiener Stadtwerke Group Full time

    Über unsWir, die Wiener Stadtwerke Gruppe, machen Wien zu einer lebenswerten Stadt. Unsere digitale Infrastruktur ermöglicht es uns, einen wichtigen Beitrag zum Wohlbefinden unserer Bürger und zur nachhaltigen Entwicklung der Stadt zu leisten.Weiterhin suchen wir in unserem Team eine engagierte Person, die als Quality Assurance Specialist bei der...


  • Copenhagen, Copenhagen, Denmark 3Shape Full time

    About the roleWe are seeking a skilled Quality Assurance Specialist to contribute to developing dental systems, combining hardware and software components. This specialist will work on improving the quality aspect in our development projects as part of a cross-functional team.You will collaborate with colleagues from R&D, product development, scientific...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    We are seeking a highly skilled Medical Device QA/RA specialist to join our Clinical and Regulatory team at Radiobotics. This is an exciting opportunity for someone with experience in quality assurance and regulatory affairs, who is passionate about ensuring the highest standards of product quality.Company OverviewRadiobotics is a leading company in the...


  • Copenhagen, Copenhagen, Denmark The HubDanske Bank Full time

    About the Role:This is an exciting opportunity to join our team as a Medical Device Quality Assurance Specialist. As a key member of our Clinical and Regulatory team, you will be responsible for ensuring that our medical devices meet the highest quality standards. Your expertise in quality assurance and regulatory affairs will play a crucial role in driving...


  • Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    We are offering a unique opportunity for an innovative and forward-thinking quality assurance professional to establish and develop a new role within our Quality Assurance department. In this position, you will have the freedom to shape and define this role from the ground up, working closely with senior leadership to influence the direction of quality...


  • Copenhagen, Copenhagen, Denmark 3Shape Full time

    About the role We are seeking a Quality Assurance Specialist to contribute to developing scanner systems, a combination of hardware and software systems in the medical device domain. You will work on improving the quality aspect in our development projects as part of a cross-functional team. You will work with colleagues across R&D, product development,...


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

    We are looking for a skilled CMC Biologics Technical Lead to join our team. As our new lead, you will be responsible for leading quality control activities with a focus on drug-device combination products.You will work closely with cross-functional teams, including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs. Your...


  • Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    Radiobotics ApS is seeking a highly skilled QA/RA expert to join our Clinical and Regulatory team. As a Medical Device Quality Assurance Specialist, you will play a pivotal role in ensuring the superior product quality and regulatory compliance of our medical devices.The ideal candidate will have at least 1 year of experience in quality assurance and/or...


  • Copenhagen, Copenhagen, Denmark Accutics ApS Full time

    About Accutics ApSAccutics ApS is a SaaS company that empowers businesses to harness and streamline their marketing data. Our team prides itself on innovation, technical excellence, and collaboration.We're committed to delivering high-quality features that meet the needs of our customers. As a QA Engineer at Accutics ApS, you'll play a key role in shaping...


  • Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

    At Radiometer Danmark, we're pushing the boundaries of medical device technology to improve global healthcare. As a Quality Assurance Specialist for Medical Devices, you'll play a critical role in ensuring our products meet the highest standards of quality and compliance.The successful candidate will have a strong background in quality management systems,...


  • Copenhagen, Copenhagen, Denmark AGC Biologics Full time

    We are seeking a skilled and motivated Biologics Manufacturing Technician to join our team in Copenhagen. As a key member of the Plant Engineering team, you will be responsible for maintaining our production and utility systems, ensuring seamless operations and high-quality product delivery.This role involves both practical and administrative...