CMC Development Expert
3 days ago
We are seeking a highly skilled CMC Development Expert to join our QA Academic team at Lundbeck A/S, H.
In this role, you will be responsible for ensuring patient safety and GMP compliance of Investigational Medicinal Products (IMPs) used in clinical trials. This involves reviewing batch records, assessing QA deviations, change controls, and laboratory deviations, as well as approving master batch records.
You will work collaboratively with stakeholders across CMC to develop and implement quality processes that support the development of new treatments for brain diseases. Our CMC Development QA organization is a global team of approximately 20 professionals based in Copenhagen and Seattle, US.
To be successful in this role, you will need a minimum of a master's degree in a relevant field, such as pharmacy, chemistry, or biology. Relevant work experience in a GMP regulated environment is also essential, as is strong communication and organizational skills. Fluency in English is required.
At Lundbeck, we are committed to creating a workplace that fosters growth, innovation, and teamwork. If you are a motivated and results-driven professional looking for a new challenge, please consider applying for this exciting opportunity.
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CMC Project Manager
7 days ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeJob Description:We are seeking a skilled CMC Project Manager to lead our team in the development of new drugs. As a key member of our Global CMC-Development team, you will be responsible for managing projects from pre-clinical to clinical phases and ensuring timely delivery of high-quality results.About the Role:You will work closely with cross-functional...
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Project Management Professional in CMC
7 days ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeRole Summary:We are seeking a skilled CMC Project Manager to join our team and lead the development of new drugs. This is an exciting opportunity to contribute to the growth of our company and work collaboratively with a diverse team of experts.About the Position:This role involves managing projects from pre-clinical to clinical phases, working closely with...
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Senior CMC Project Manager
1 week ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeDo you bring Project Management skills from working in a development area? Do you have experience within Biologics and working with CDMOs? Join us from the beginning of a new drug development project and be part of our exciting journey in Global CMC-Development.The positionYou will as CMC Project Manager join Global CMC-Development with approximately 50...
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Senior CMC Project Manager
7 days ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeDo you bring Project Management skills from working in a development area? Do you have experience within Biologics and working with CDMOs? Join us from the beginning of a new drug development project and be part of our exciting journey in Global CMC-Development. The position You will as CMC Project Manager join Global CMC-Development with approximately 50...
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CMC Development Quality Assurance Specialist
7 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeIn this exciting role, you will join our growing department with an anticipated future expansion of new drug candidates. As a CMC Development Quality Assurance Specialist, you will support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the IMP for clinical trials.Your responsibilities will...
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Global CMC Director
22 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.We're looking for a Global CMC Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational...
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CMC Technical Integration Lead
19 hours ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe 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...
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CMC Technical Integration Manager
1 day 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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Senior CMC Stability Associate
3 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 and Global Regulatory Affairs Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAbout the JobGenmab A/S is seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeJob OverviewWe are seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team at Genmab A/S. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing...
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QA Academic, CMC
7 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeWould you like to contribute to the development of new treatments for brain diseases by ensuring patient safety and GMP compliant Investigational Medicinal Product (IMP) to clinical trials? Then this is a great opportunity to join our team collaborating with multiple stakeholders while leveraging your professional and personal skills. We offer an exciting...
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CMC Analytical Specialist
3 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 Biologics Quality Assurance Specialist
2 days ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout Our TeamIn CMC Biologics, we are more than 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA.Most of the teams in the CMC Biologics organization has employees based in both Copenhagen and Seattle; this is also the case for your new department, Quality...
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CMC Project Assistant
6 days ago
Copenhagen, Copenhagen, Denmark AGC Inc Full timeCMC Project Assistant (12 month maternity cover) CMC Project Assistant (12 month maternity cover) Apply locations Copenhagen, Denmark time type Full time posted on Posted 2 Days Ago time left to apply End Date: March 26, 2025 (18 days left to apply) job requisition id JR101718 Our purpose is to bring hope to life by enabling life-changing therapies for...
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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 Life-cycle and Commercial Project Manager
3 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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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 Lundbeck AS, H Full timeLundbeck A/S is a global pharmaceutical company dedicated to transforming lives through innovative treatments for brain disorders. As a leading developer of life-changing medicines, we strive to make a meaningful difference in the lives of people affected by these conditions.As a Regulatory Expert in Pharmaceutical Quality Assurance, you will play a crucial...