Chief Manufacturing Biotech Project Lead

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We 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 Responsibilities
  • Manage CMC activities at Contract Manufacturing Organizations (CMOs), with a focus on Drug Product manufacturing
  • Ensure alignment within the CMC Management Team governing a CMC program within Genmab
  • Support the CMC Lead for strategy and execution of CMC late stage development activities towards BLA/MAA submission
  • Author and review regulatory CMC submissions (BLA, MAA, JNDA)
  • Support quality events related to CMOs and internal processes
Requirements
  • At least 3-5 years of experience in CMC project management
  • Experience working with biopharmaceuticals, preferably therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale
  • Proven track record and technical skills in biological process development and biopharmaceutical manufacturing
  • Familiarity with Contract Manufacturing Organizations (CMOs) and GMP knowledge
  • Excellent communication skills in English, written and oral
About You
  • You are passionate about Genmab's mission to transform lives through innovative cancer treatment
  • You bring rigor and excellence to your work and believe in Genmab's rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds


  • Copenhagen, Copenhagen, Denmark Reshape Biotech Full time

    We are seeking an experienced Senior Biotech Innovation Manager to lead our application team at Reshape Biotech. The ideal candidate will have a strong background in biotechnology research and development, with a proven track record of delivering results across a wide range of projects.In this role, you will work closely with our customer experience,...


  • Copenhagen, Copenhagen, Denmark AM Group Full time

    We apply simple, reliable management tools at AM Group to improve our clients' business.In this role, you will contribute to the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities.The responsibilities include developing test packages, coordinating and executing commissioning and...

  • Chief of Staff

    6 days ago


    Copenhagen, Copenhagen, Denmark Walker Cole International Full time

    Chief of Staff (Manufacturing and Supply) Walker Cole have partnered with a leading European pharmaceutical business to identify a Chief of Staff to lead a business-wide transformation across the manufacturing and supply function. This role will sit in the office of the COO and is integral in the execution of strategic change management programs globally....


  • Copenhagen, Copenhagen, Denmark Again Full time

    Join us in our quest to make carbon-negative chemicals a reality. At Again, we're not just building a business – we're creating a movement. As our Technical Chief of Staff, you'll be part of a dynamic team that's passionate about revolutionizing the chemical industry.This is an exceptional opportunity to work on challenging and meaningful projects that...

  • Applications lead

    12 hours ago


    Copenhagen, Copenhagen, Denmark Reshape Biotech Full time

    At Reshape we don't just challenge the status quo of biotech today. Our goal is to redefine biotechnology research for the future. We believe that biology holds the key to a sustainable future. We want to provide the most innovative companies with the tools to decode nature in order to address some of humanity's biggest challenges — from revolutionizing...


  • Copenhagen, Copenhagen, Denmark IPS-Integrated Project Services Full time

    Job Description At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a Project Planner/Scheduler to join our team at our office located in Copenhagen, Denmark . You will...


  • Copenhagen, Copenhagen, Denmark Blackfield Associates Full time

    International Automation Expert at Blackfield Associates | PLC | DCS | MESThis is an on-site position.VISA sponsorship available for the right candidate.We are seeking an experienced Automation Project Manager to support the delivery and execution of BMS (Building Management Systems) and VDS/EMS systems packages for a large-scale CAPEX investment project.Key...


  • Copenhagen, Copenhagen, Denmark Ramboll Full time

    Chief Consultant Advisory – Wind Turbine Supply Chain and Manufacturing Full-time Overview As our new Wind Turbine Chief Consultant, you will be part of our global Offshore Wind Advisory team. You will engage with various stakeholders supporting project development across all stages, from early conceptual design until project execution and package...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    We are seeking an experienced Automation Project Lead to manage the delivery of PI data historian, MES, and Infobatch reporting systems for a 12-month contract with a leading biotech company. This onsite role requires a strong background in automation, MES, PI data historian, and Infobatch systems within the pharmaceutical or biotech sector.Key...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    We are currently seeking an experienced Automation Project Manager for a 12-month contract with a leading biotech company. This role will be onsite and requires a strong background in automation, MES, PI data historian, and Infobatch systems within the pharmaceutical or biotech sector.Key Responsibilities:Manage the delivery of PI data historian, MES, and...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    We are currently seeking an experienced Automation Project Manager for a 12-month contract with a leading biotech company. This role will be onsite and requires a strong background in automation, MES, PI data historian, and Infobatch systems within the pharmaceutical or biotech sector. Key Responsibilities: Manage the delivery of PI data historian, MES, and...


  • Copenhagen, Copenhagen, Denmark Cognizant Life Sciences Manufacturing Full time

    2 days ago Be among the first 25 applicants Direct message the job poster from Cognizant Life Sciences Manufacturing Talent Acquisition Specialist @ Cognizant Life Science Manufacturing | CIPD Job Title: Technical Project Manager (Data Historians) Job Summary: The Technical Project Manager is responsible for the overall technical delivery of the project,...

  • Project Coordinator

    9 hours ago


    Copenhagen, Copenhagen, Denmark AGC Inc Full time

    We are seeking a skilled CMC Project Assistant to join our dynamic team in Copenhagen. As part of this role, you will provide crucial support across the spectrum of planning, organizing, and reporting in multifunctional project areas.The ideal candidate will possess a solid background in pharmaceutical or biotech sectors with expertise in process development...


  • Copenhagen, Copenhagen, Denmark Hamlyn Williams Full time

    We are currently seeking a highly experienced Automation Project Lead to join our team at Hamlyn Williams for a 12-month contract. This onsite role requires a strong background in automation, MES, PI data historian, and Infobatch systems within the pharmaceutical or biotech sector.Key Responsibilities:Manage the delivery of PI data historian, MES, and...


  • Copenhagen, Copenhagen, Denmark Blackfield Associates Full time

    Direct message the job poster from Blackfield Associates International Automation Consultant at Blackfield Associates | PLC | DCS | MES | This is an on-site position For the right candidate, VISA could be sponsored Due to the growth of one of our key biotech clients in Copenhagen, Denmark - Blackfield Associates are looking for an Automation Project...


  • Copenhagen, Copenhagen, Denmark Again Full time

    We're on a mission to revolutionize the chemical industry by making carbon-negative chemicals. At Again, we're driven by a shared vision to reduce over 1 gigaton of CO2. As our Technical Chief of Staff, you'll play a pivotal role in shaping this journey.This is a unique opportunity to work alongside our experienced founders and contribute to the growth of a...


  • Copenhagen, Copenhagen, Denmark Reshape Biotech Full time

    We are looking for a talented Biotechnology Research and Development Leader to join our team at Reshape Biotech. As a key member of our organization, you will be responsible for leading our application team and driving innovation in biotechnology research and development.The successful candidate will have a strong background in biotechnology research and...


  • Copenhagen, Copenhagen, Denmark Reshape Biotech Full time

    We are seeking a highly skilled Strategic Applications Director to join our team at Reshape Biotech. As a key member of our organization, you will be responsible for leading our application team and developing strategic plans to drive business growth.The successful candidate will have a strong background in biotechnology research and development, with a...


  • Copenhagen, Copenhagen, Denmark Blackfield Associates Full time

    Blackfield Associates is seeking an experienced Automation Project Lead to support the delivery of a large-scale Building Management Systems (BMS) and Distributed Control Systems (DCS) project in Copenhagen, Denmark.Key Responsibilities:Lead the planning, execution, and delivery of BMS and VDS system packages, ensuring project milestones are met.Collaborate...


  • Copenhagen, Copenhagen, Denmark Again Full time

    About Again Again makes carbon negative chemicals for a cleaner future. We are the first carbon negative chemical manufacturer that can scale to meet global demand. The best thing about it: we use carbon dioxide as a feedstock. We are currently at an exciting inflection point of our growth journey developing our first commercial plant. We have raised over...