CMC Strategy Lead

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Company Overview

Genmab is an international biotechnology company dedicated to developing next-generation antibody therapeutics. Our team is passionate about improving lives through innovative medicines.

We've built a robust pipeline of differentiated antibody platforms, including bispecific T-cell engagers, immune checkpoint modulators, and antibody-drug conjugates. Our collaborations with leading pharmaceutical companies have enabled us to accelerate the development of transformative treatments.

About This Opportunity:

  • Join our dynamic team as a Director/Associate Director, Global Regulatory Affairs and contribute to our mission to transform lives.
  • Leverage your expertise in CMC regulatory affairs to drive strategic decision-making and collaborative efforts.
  • Work closely with our cross-functional teams to ensure seamless development and commercialization of our innovative products.

Your Qualifications:

  • Master of Science in pharmacy, engineering, or equivalent.
  • Minimum 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
  • A track record in moving therapeutic products through various stages of development.
  • Experience with preparation of BLAs and preferably lifecycle management.
  • Excellent communication skills in English (verbal and written).


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We 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...


  • Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

    We are looking for a Senior CMC Project Manager to join our Global CMC-Development team at ALK-Abelló A/S. As a key member of the team, you will be responsible for managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.Your key responsibilities will include:Leading...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Job DescriptionThe Director of CMC will lead the development and implementation of CMC strategies, ensuring manufacturing, supply chain, and Quality Management Systems align with the company's overall strategic objectives. Responsibilities include:Developing Technical Operations strategies for early and late-phase drug development in collaboration with...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Main ResponsibilitiesThe successful candidate will have the following key responsibilities:Lead the development and implementation of CMC strategies.Collaborate with cross-functional teams to develop technical operations strategies.Ensure alignment between manufacturing, supply chain, and Quality Management Systems.


  • Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

    Do 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...


  • Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

    Do 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...

  • CMC Project Manager

    3 hours ago


    Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

    Job 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...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the OpportunityWe are seeking a highly motivated CMC Technical Integration Manager to join our team in New Product Introduction (NPI) CMC. As a key member of the CMC Integration Team, you will be responsible for developing and supporting analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.Your primary focus...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • 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 Genmab Full time

    We 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time

    As a Senior CMC Project Manager at ALK-Abelló A/S, you will be part of our Global CMC-Development team. This team is responsible for managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.The position involves working closely with cross-functional teams to prepare...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    About the PositionWe are looking for an experienced CMC Technical Integration Manager to join our CMC Operations team in Copenhagen. As a Senior CMC Process Manager, you will be responsible for developing and implementing analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.Your primary focus will be on integrating...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly skilled Senior Project Manager to join our Late-stage Manufacturing Development (LSMD) Team in Copenhagen. As a key member of the CMC Operations team, you will play a vital role in supporting the development and manufacture of Genmab's antibody drugs used in preclinical, clinical, and commercial settings.Key...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the PositionWe are seeking a Senior Project Manager to join our Late-stage Manufacturing Development (LSMD) Team in Copenhagen. This is a unique opportunity to contribute to the development and manufacture of Genmab's antibody drugs and be part of a team that is dedicated to transforming lives through innovative cancer treatment.Key Responsibilities...