CMC Development Lead
5 days ago
This is an exciting opportunity to join ALK-Abelló A/S, a global pharmaceutical company specializing in allergy immunotherapy. We are driven by professionalism, integrity, and a commitment to creating a fun and inspiring working environment.
The successful candidate will work closely with cross-functional teams to prepare project plans and execute CMC activities. This includes developing and maintaining CMC project plans, timelines, and budgets, as well as overseeing internal CMC activities and ensuring alignment with project expectations.
- Main Responsibilities:
- Chair the CMC project team and ensure clear direction and communication.
- Develop and maintain CMC project plans, timelines, and budgets.
- Represent G-CMC in the Project Core Team and manage stakeholders.
- A master's degree in engineering, natural science, or equivalent.
- At least 5 years of experience in drug development, Biologics.
- Proven project management skills from a development environment and ability to lead cross-functional teams.
-
CMC Operations Lead
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe're searching for a highly skilled Senior Project Manager CMC to join our LSMD Team in Copenhagen. As a key member of our team, you'll be responsible for coordinating and planning activities performed at our partnered CMOs. You'll work closely with Subject Matter Experts (SMEs) to ensure that Genmab's products meet the latest industry...
-
CMC Project Lead
2 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeJob Description:This role sits at the crossroads of science, execution, and leadership.Lead cross-functional CMC development projects from proposal through delivery in collaboration with external stakeholdersInterface directly with technical teams and external stakeholders — you're the translator and the driverCoordinate inputs across Process Development,...
-
Global CMC Lead
6 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics.We are seeking a Director/Associate Director to join our Regulatory Affairs CMC team, responsible for providing operational and strategic regulatory CMC input to support worldwide development and...
-
CMC Project Lead
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab is an international biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. We strive to build extraordinary futures together by inventing next-generation antibody technology platforms and leveraging translational research and data sciences.The Job DescriptionWe are seeking a...
-
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...
-
Senior CMC Project Manager
2 weeks 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...
-
CMC Project Manager
2 days ago
Copenhagen, Copenhagen, Denmark Black Swans Exist Full timeDelivery Manager | Process Development | Life Science RecruitmentCMC Project ManagerSome projects are complicated.Yours will be complex.This role sits at the crossroads of science, execution, and leadership. You're not just managing timelines — you're aligning stakeholders, navigating technical depth, and keeping the full CMC scope moving with intention...
-
CMC Technical Integration Manager
3 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 Workday@Genmab.com.(Senior) CMC Technical Integration ManagerLocations: CopenhagenTime Type: Full timePosted on: Posted 2 Days AgoJob Requisition ID: R11639At Genmab, we're committed to building...
-
CMC Regulatory Affairs Specialist
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWhy Join UsGenmab offers a unique opportunity to work with a talented team of professionals who share a passion for innovation and excellence. As a member of our Regulatory Affairs CMC team, you will have the chance to develop and execute global regulatory CMC strategies, collaborate with cross-functional teams, and prepare CMC documentation for various...
-
Global CMC Strategy Leader
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout UsAt Genmab, we're passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment. We believe in being proud of our uniqueness, determined to be our best, and authentic in all that we do.Job DescriptionWe're seeking an exceptional individual to join our Regulatory Affairs CMC...
-
Biologics Development Lead
2 days ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeResponsibilitiesProject Planning and Execution: Develop and maintain project plans, timelines, and budgets, and oversee internal CMC activities.Stakeholder Management: Represent the Global CMC area in the Project Core Team and ensure CMC deliverables align with overall project expectations.Collaboration and Communication: Work closely with cross-functional...
-
CMC Project Manager Position
2 days ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeJob DescriptionWe are seeking an experienced CMC Project Manager to join our Global CMC-Development team in Denmark and the US. This role will involve working on various projects, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.The ideal candidate will have a strong background in project management,...
-
CMC Specialist for Genmab
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeCancer Treatment Innovations: Join the Genmab TeamThe Role & DepartmentAs a key member of our Clinical Pipeline, this exciting growth period presents an exceptional opportunity for a Senior Associate to join our CMC Stability team in Denmark. Reporting to the Team Lead for the Stability team, you will work collaboratively with colleagues, CMC Project...
-
Senior CMC Manager
3 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAs a (Senior) CMC Technical Integration Manager at Genmab, you will play a critical role in the development and implementation of analytical/process strategies for selected projects. You will work closely with the CMC PM team to ensure technical excellence, regulatory compliance, and speed into First-in-Human trials.About the RoleThis is an exciting...
-
Late Stage Manufacturing Development Manager
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole OverviewThe Senior CMC Project Manager will play a crucial role in supporting the CMC Lead and coordinating planning of activities performed at our partnered Contract Manufacturing Organizations (CMOs). As part of our Late-Stage Manufacturing Development (LSMD) Team in Copenhagen, you'll contribute to ensuring that Genmab's products meet the latest...
-
Scientific Process Development Lead
6 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeWe are looking for a skilled and motivated individual to take on the role of Scientific Process Development Lead. As part of our Chemistry, Manufacturing and Control (CMC) Development & Scaling team at Novo Nordisk, you will be responsible for developing and scaling up processes to purify and dry proteins for clinical trials.The ideal candidate will have a...
-
Senior Associate CMC for the Stability Team
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering 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, we believe that being...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering 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, we believe that being...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeKey ResponsibilitiesThis role requires a highly organized and detail-focused Senior Associate CMC to oversee stability activities and ensure compliance with project timelines and regulatory requirements. Key responsibilities include:Managing stability protocols, data, and reports.Participating in process improvements and implementing changes.Collaborating...
-
Senior Pharmaceutical Project Coordinator
5 days ago
Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full timeJob SummaryALK-Abelló A/S is seeking a Senior Pharmaceutical Project Coordinator to join our Global CMC-Development team. The successful candidate will have experience in drug development, Biologics, and proven project management skills from a development environment.In this role, you will be responsible for leading cross-functional teams in preparing...