CMC Integration Specialist
4 days ago
We are seeking a highly skilled and experienced Senior Technical Operations Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC at Genmab A/S. The successful candidate will be responsible for developing and supporting required analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.
Key Responsibilities- Integration of new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.
- Managing specific analytical/process activities at Contract Manufacturing Organizations (CMOs) related to Early-Stage projects, ensuring technical excellence and speed into First-in-Human trials.
- Supporting the CMC Project Management team to solve project-specific analytical/process tasks with a holistic CMC approach for new antibody modalities or CMC challenges like transfer to new manufacturing sites.
- Supporting and reviewing regulatory CMC submissions (IND/CTA).
- SUPPORTING AND FOLLOWING UP ON CMO AND INTERNAL QUALITY EVENTS SUCH AS CHANGES OR DEVIATIONS.
- You bring a broad background from CMC development within Bioprocess Technology/Bioprocess Analytics.
- You have experience working in a fast-growing, dynamic company or a strong desire to.
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best and take pride in enabling the best work of others on the team.
- You are not afraid to grapple with the unknown and be innovative.
- You have basic knowledge of Project Management tools.
Genmab 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. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
Benefits- The estimated annual salary for this position is around $120,000 - $180,000 depending on experience.
- Genmab A/S offers a comprehensive benefits package including health insurance, retirement savings plan, and paid time off.
This role offers a unique opportunity to work with a leading biotechnology company, develop your skills and expertise, and contribute to the development of innovative cancer treatments.
-
Expert CMC Technical Integration Specialist
1 month ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are committed to building extraordinary futures together, by developing innovative products and pioneering therapies that change the lives of patients and the future of cancer treatment.Genmab is now searching for a (Senior) CMC Technical Integration Manager to join the CMC Integration Team in New Product Introduction (NPI) CMC. The NPI CMC Team is...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab A/S, we're committed to delivering exceptional biopharmaceutical products and pioneering therapies that transform the lives of patients. As a highly skilled professional in our CMC Integration Team, you will play a pivotal role in developing innovative solutions for early-stage CMC development. Our team is responsible for creating cutting-edge...
-
Chief Technical Integration Director
2 months ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we are dedicated to transforming the lives of patients through innovative cancer treatment.About the RoleWe are seeking a skilled Clinical Manufacturing and Control (CMC) Technical Integration Director to join our team in Copenhagen. As a CMC Technical Integration Director, you will play a vital role in developing and implementing...
-
Senior Associate CMC for the Stability Team
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeExcel in a Fast-Paced Environment as Senior Associate CMCAt Genmab, we strive to revolutionize cancer treatment and improve patient lives through innovative therapies. As a key member of our clinical pipeline team, you will contribute to shaping the future of antibody products.About the Role:You will work closely with colleagues in the CMC Stability team,...
-
Automation Systems Manager
1 day ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled Automation Systems Manager to join our Chemistry, Manufacturing and Control (CMC) Development & Scaling team in Novo Nordisk PSQIT organisation.As part of the IT & Automation team within CMC API Pilots, you will be responsible for ensuring stable and efficient operation of our IT/OT systems, keeping them in...
-
Signalisation IT Integration Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Hitachi Rail Full timeHitachi Rail is seeking a talented Signalisation IT Integration Specialist to join our dynamic team in Copenhagen, Denmark.About the RoleIn this exciting position, you will play a crucial role in modernizing Denmark's railway network by integrating cutting-edge technology into our signalling system. As a Signalisation IT Integration Specialist, you will be...
-
Copenhagen, Copenhagen, Denmark Nordea Bank Norge ASA Full timeNordea Bank Norge ASA is a leading financial institution in the Nordic region, offering a wide range of banking services to individuals, businesses, and institutions.We are currently seeking a highly skilled Data Integration Specialist to join our team in Copenhagen. This is an exciting opportunity to work with cutting-edge technology and contribute to the...
-
Programmatic Integration Specialist Lead
4 days ago
Copenhagen, Copenhagen, Denmark Better Collective Full timeAbout Better CollectiveBetter Collective is a leading sports betting media group that provides users with educational content, bookmaker information, and betting tips. Our mission is to make sports betting and gambling entertaining, transparent, and fair.Competitive Salary PackageWe offer a competitive salary package of approximately €60,000 - €90,000...
-
Strategic Finance Integration Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeRole OverviewWe are seeking an experienced Strategic Finance Integration Specialist to join our team at Novo Nordisk A/S. In this role, you will lead and facilitate full finance integration across our global operations, driving change management and process improvement.Key ResponsibilitiesDesign, plan, set up, and operationalize full finance integration...
-
Retail Solutions Integration Specialist
1 month ago
Copenhagen, Copenhagen, Denmark DFDS AS Full timeWe are seeking a skilled Retail Application Specialist to join our team at DFDS A/S.This role involves supporting the existing retail network across our fleets and implementing retail solutions on new vessels joining our passenger network.As a Retail Application Specialist, you will be part of the Retail Technology team within the Passenger Tribe in our T&I...
-
Senior Workflow Automation Specialist
6 days ago
Copenhagen, Copenhagen, Denmark Hays Specialist Recruitment Full timeA challenging opportunity for a skilled Workflow Automation Specialist has arisen at Hays Denmark. We are looking for an expert with experience in developing and implementing workflow automation solutions using Python, Bash, PowerShell, or .NET scripting languages.This role requires strong analytical and problem-solving skills to optimize network...
-
Digital Programmatic Integration Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Better Collective Full timeAt Better Collective, a leading sports betting media group, we're seeking an experienced Digital Programmatic Integration Specialist to drive our programmatic revenue growth in the esports sector. As part of our continued expansion, you will play a pivotal role in developing and executing strategies that maximize revenue from programmatic ad sales across our...
-
Research Formulation Specialist
2 months ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAbout the RoleLundbeck's commitment to restoring healthy mental well-being drives our passion for developing innovative treatments that improve lives. As a Research Formulation Specialist in Pharmaceutical Development, you will be part of a dynamic team responsible for preformulation development.The ideal candidate will have a strong scientific background in...
-
Copenhagen, Copenhagen, Denmark Blackswansexist Full timeSenior CMC Specialist Job DescriptionWe are seeking an experienced Senior CMC Specialist to lead small-molecule drug substance projects from candidate selection to commercialization.Key Responsibilities:Lead drug substance development for small molecule drug projects from candidate selection to late stage and commercializationDrive cross-functional CMC and...
-
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeJob DescriptionWe are seeking an experienced Senior Quality Control Scientist to join our CMC Biologics team at H. Lundbeck A/S.About the RoleThis is a great opportunity to work as a technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products.You will be working closely with contract manufacturing...
-
Signalling IT Integration Specialist
7 hours ago
Copenhagen, Copenhagen, Denmark Thales e-Security, Inc. Full timeAbout the RoleWe are seeking a highly skilled Signalling IT Test and Integration Engineer to join our dynamic team at Hitachi Rail GTS Denmark A/S. As a key member of our engineering team, you will play a crucial role in modernizing Denmark's railway network by implementing the European Train Control System (ETCS).Job DescriptionTest and integrate system...
-
Healthcare Systems Specialist
1 month ago
Copenhagen, Copenhagen, Denmark WHO - World Health Organization Full timeThe World Health Organization (WHO) is seeking a skilled Healthcare Systems Specialist to join its team. This role will focus on implementing integrated care models in Member States of the WHO European Region.Job DescriptionThis position involves providing technical support and guidance to countries in designing and implementing health services reforms, with...
-
Copenhagen, Copenhagen, Denmark GE Full timeUnlock New Opportunities in Grid SolutionsWe are seeking an experienced High Voltage DC Systems Integration Specialist to join our team at GE Grid Solutions. As a key member of our Grid Systems Integration Business Line, you will be responsible for driving growth and delivering high-quality solutions to our customers.About the RoleThis is an exceptional...
-
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeLundbeck's mission is to restore healthy mental well-being, allowing individuals to reach their full potential. We pursue innovative treatments that significantly improve the lives of people living with brain diseases.We are currently seeking an experienced pharmaceutical specialist in preformulation for a new position within Pharmaceutical Development. The...
-
Data Integration Specialist
5 days ago
Copenhagen, Copenhagen, Denmark RELEX Solutions Full timeAt RELEX Solutions, we're shaping the future of retail and consumer brands by creating cutting-edge optimisation software. Our company overview highlights our focus on growth and innovation, driving profitable expansion for our clients.We're seeking a full-time Technical Consultant to join our team in Oslo, Stockholm or Copenhagen, providing flexible and...