CMC Biologics Technical Lead
5 days ago
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 primary responsibility will be to ensure that all quality-related tasks are completed efficiently and effectively.
This position requires excellent leadership skills, strong communication abilities, and a deep understanding of pharmaceutical regulations. You should also have experience working in a matrix environment and be able to prioritize tasks accordingly.
The ideal candidate will have a degree in a relevant field and at least 7 years of experience in the biotech or pharmaceutical industry.
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CMC Regulatory Team Lead
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeCompany OverviewGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. With a core purpose guiding its team, Genmab has invented next-generation antibody technology platforms and leveraged translational research and data sciences.Job DescriptionWe are seeking a highly...
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CMC Technical Integration Manager
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at (Senior) CMC Technical Integration Manager Locations: Copenhagen Time Type: Full time Posted on: Posted 2 Days Ago Job Requisition ID: R11639 At Genmab, we're committed to building extraordinary...
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Biopharmaceutical CMC Leadership Role
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob SummaryWe're looking for a highly skilled Biopharmaceutical CMC Leadership Role professional to join our Regulatory Affairs CMC team. As a Team Lead, you will be responsible for leading a sub-team while actively contributing to regulatory projects. Your experience in developing and executing CMC strategies, collaborating with cross-functional teams, and...
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Regulatory Affairs Associate Director
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe're expanding our team and seeking a seasoned Regulatory Affairs Associate Director - Biologics to join our Regulatory Affairs CMC team. As a Team Lead, you will lead a sub-team while actively contributing to regulatory projects. Your experience in developing and executing CMC strategies, interacting with health authorities, and ensuring...
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Biologics Regulatory Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are seeking a highly experienced Biologics Regulatory Specialist to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for providing regulatory expertise and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of global...
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CMC Strategy Manager
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are looking for a highly skilled CMC Strategy Manager to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for developing and executing sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.The ideal candidate will have a...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the Role Genmab is now searching for two (Senior) CMC Technical Integration Managers to join the CMC Integration Team in New Product Introduction (NPI) CMC. The NPI team is responsible for Early-Stage CMC development covering preclinical to early/mid clinical stage CMC work. Key Responsibilities Include:Integration of new/specific required...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
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Senior CMC Stability Associate
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
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CMC Analytical Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
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Biologics Manufacturing Technician
5 days ago
Copenhagen, Copenhagen, Denmark AGC Biologics Full timeWe 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...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the Position This position could be the perfect match for your personal development if you have a proven track record and the technical skills of biological process or analytical development and biopharmaceutical manufacturing. You should also have a very good knowledge of the principles of GMP and CMC development within the biopharmaceutical industry....
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Biologics Quality Assurance Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeLundbeck 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...
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Senior CMC Project Manager
23 minutes ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science,...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
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CMC Process Development Manager
7 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob Overview As (Senior) CMC Technical Integration Manager, you will be developing and supporting the required analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio. You will integrate these strategies into projects where the CMC development path is deviating from the Genmab CMC platform and where specific...
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Global Regulatory Lead
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are looking for a highly skilled Global Regulatory Lead to join our Regulatory Affairs CMC team at Genmab A/S. As a key member of our team, you will be responsible for providing strategic regulatory guidance and support for the development and commercialization of our biologic products.The ideal candidate will have a strong understanding of global...
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Biologics QC Team Lead
7 days ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeJob RequirementsTo be successful in this role, you will need to have a deep understanding of Quality Control processes and procedures, as well as excellent communication and collaboration skills. You will also need to be able to work effectively in a fast-paced environment with changing priorities.About the RoleThis is an exciting opportunity to join a...
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CMC Stability Team Lead
1 day ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are seeking a talented Senior Associate CMC for the Stability Team to join our dynamic team in Copenhagen, Denmark. As a key member of our team, you will be responsible for ensuring the stability activities are conducted compliantly and according to project timelines. You will work closely with the CMC Project Manager, QA, and CMOs to handle stability...