CMC Project Manager

3 days ago

Copenhagen Metropolitan Area, Denmark Black Swans Exist Full time 80,000 - 120,000 per year

CMC Project Manager

Location:
Denmark (biotech company)

Start date:
February

Seniority:
Mid-level PM (junior PMs with strong execution skills will also be considered)

About the Role

A dynamic and fast-growing biotech company is seeking a highly driven and execution-focused
CMC Project Manager
with strong experience in Peptides or biologics CMC development. The role sits at the core of the company's preclinical and translational activities as it advances a key program through completion of the full CMC package, toxicology studies, and preparation for Phase I readiness (targeted for Q2 the following year).

The selected candidate will function as the operational link between
CMC, Regulatory Affairs, Toxicology, and Clinical
, ensuring precise coordination, high-quality documentation, and timely delivery across all workstreams. This position suits someone who thrives in busy, fast-paced environments, enjoys hands-on project execution, and excels at keeping cross-functional teams aligned.

Experience working with
WuXi
or similar CDMOs is considered an advantage.

Key Responsibilities

CMC Program Leadership

  • Lead and coordinate all CMC development activities (peptide experience is beneficial but not essential).
  • Manage external CDMO interactions, ideally with prior exposure to WuXi processes.
  • Drive progress, risk mitigation, and decision-making across core CMC workstreams.

Cross-Functional Project Management

  • Drive the CMC + RA + Clinical data package, ensuring smooth communication and alignment.
  • Prepare, facilitate, and follow up on team meetings, including responsibility for drafting high-quality, CMC-focused documentation.
  • Maintain and update timelines, deliverables, and project trackers covering preclinical, tox, and CMC work.

Preclinical & Translational Coordination

  • Support preclinical and translational activities throughout the first project year (this is essential).
  • Align tox planning with CMC progress and regulatory expectations.
  • Lead preparation efforts for regulatory submissions related to Phase I initiation.

Execution & Delivery

  • Take operational ownership for timelines leading to:
  • Completion of the CMC package (within 12 months)
  • Completion of toxicology studies
  • Phase I readiness (Q2 2027 target)
  • Proactively resolve issues and maintain momentum in a high-intensity environment.

Qualifications

Must-Haves

  • Strong background in
    CMC development for Peptides or biologics
    (formulation, analytics, manufacturing, tech transfer, or related areas).
  • Demonstrated project execution capabilities—comfortable owning timelines and driving teams under pressure.
  • Experience with preclinical or translational development activities.
  • Excellent cross-functional communication skills and experience producing technically strong, CMC-heavy meeting documentation.
  • Capability to collaborate effectively with external CDMOs (WuXi experience highly valued).

Nice-to-Haves

  • Background in peptide development.
  • Experience in early-stage biotech companies.
  • Familiarity with regulatory expectations for first-in-human filings.

Personal Profile

  • Hands-on, structured, and proactive; thrives on delivering results.
  • Comfortable operating in environments with multiple parallel workstreams.
  • Strong communicator able to keep teams aligned and committed under tight timelines.
  • Independent, resourceful, and collaborative—able to work confidently across internal and external stakeholders.

  • Director of Regulatory Affairs, CMC

    2 days ago

    Copenhagen Metropolitan Area, Denmark Hemab Therapeutics Full time 85,000 - 170,000 per year

    Hemab is seeking a Director of Regulatory Affairs, CMC to lead global regulatory strategy across our portfolio of rare disease therapies. This role provides strategic leadership for all CMC-related regulatory activities—from early development through commercialization—ensuring high-quality submissions and successful interactions with global health...

  • CMC Development Manager

    2 days ago

    Copenhagen, Copenhagen, Denmark Karo Healthcare Full time 80,000 - 120,000 per year

    Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others....

  • Senior Scientist, Drug Product Development, CMC

    2 weeks ago

    Copenhagen Metropolitan Area, Denmark Hemab Therapeutics Full time 120,000 - 240,000 per year

    Opportunities as a Senior Scientist within drug product developmentAt Hemab you will join a clinical-stage biotech company on an exciting journey to build the ultimate clotting company focusing on high unmet need for patients suffering from neglected bleeding and thrombotic disorders. Based in Copenhagen (DK) and Boston (US) Hemab offers a great working...

  • Senior Scientist, Drug Product Development, CMC

    3 days ago

    Copenhagen, Copenhagen, Denmark Servier Symphogen Full time 120,000 - 180,000 per year

    Company DescriptionServier Symphogen A/S, a Centre of Excellence for Antibodies within the Servier company, specializes in research, early clinical stages, and CMC biologics development. With a strategic focus on oncology and immune-oncology, Symphogen leverages an effective antibody platform to discover and develop novel compounds. These compounds aim to be...

  • Project Manager, Supply Chain Project Management

    3 days ago

    Copenhagen, Copenhagen, Denmark Lundbeck Full time 90,000 - 140,000 per year

    (Senior) Project Manager, Supply Chain Project ManagementDo you thrive on leading cross-functional projects and driving them to success?Can you confidently navigate a complex stakeholder landscape and influence stakeholders at all levels of an organization?Do you take a holistic approach to supply chain management, connecting the dots across functions from...

  • Project Manager, Supply Chain Project Management

    3 days ago

    Copenhagen, Copenhagen, Denmark Lundbeck Full time 100,000 - 180,000 per year

    Do you thrive on leading cross-functional projects and driving them to success?Can you confidently navigate a complex stakeholder landscape and influence stakeholders at all levels of an organization?Do you take a holistic approach to supply chain management, connecting the dots across functions from manufacturing to markets?Then this position could be the...

  • Senior CMC Analytical specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark Genmab Full time 100,000 - 150,000 per year

    At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are...

  • Project Manager, Supply Chain Project Management

    3 days ago

    Copenhagen, Copenhagen, Denmark LUNDBECK Full time 100,000 - 180,000 per year

    (Senior) Project Manager, Supply Chain Project ManagementDo you thrive on leading cross-functional projects and driving them to success?Can you confidently navigate a complex stakeholder landscape and influence stakeholders at all levels of an organization?Do you take a holistic approach to supply chain management, connecting the dots across functions from...

  • Senior CMC Analytical specialist

    3 days ago

    Copenhagen, Copenhagen, Denmark Genmab Full time 120,000 - 200,000 per year

    At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are...

  • Senior Scientist, Drug Formulation and Process Development

    3 days ago

    Copenhagen Metropolitan Area, Denmark Hemab Therapeutics Full time 120,000 - 180,000 per year

    Opportunities as a Senior Scientist within drug product development with formulation development experience & process knowledgeAt Hemab you will join a clinical-stage biotech company on an exciting journey to build the ultimate clotting company focusing on high unmet need for patients suffering from neglected bleeding and thrombotic disorders. Based in...