Senior Project Manager, CMC

Genmab A/S; København; On-site; DKK 645,000 - 967,000; Full time

Benefits offered by this job

Health insurance

Pension

Paid time off

Employee support programs

Job summary

Genmab A/S is seeking a Senior Operational CMC Project Manager to lead day-to-day CMC activities across Discovery to IND/CTA and early clinical development in Copenhagen. You will coordinate cross-functional teams, manage external CMOs/CDMOs, and drive integrated project plans to ensure timely, high-quality development programs.

You will collaborate with Process Development, Manufacturing, Regulatory, QA, and Supply Chain to translate CMC strategy into operational execution, while maintaining

Qualifications

• Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or related field.
• Approximately 8–10 years of relevant experience in CMC/biologics development.
• Proven track record leading complex CMC development activities from early development through Phase I/II.
• Strong project management experience including planning, budgeting, risks and governance.
• Solid understanding of GMP manufacturing and CMC regulatory requirements.
• Experience working with external CMOs/CDMOs and regulatory CMC submissions.
• Excellent communication, collaboration, and problem-solving skills; fluent in English.

Responsibilities

• Drive operational execution of integrated CMC development plans from Discovery through IND/CTA and Phase I/II.
• Develop and maintain integrated CMC project plans with timelines, milestones, budgets and risks.
• Coordinate day-to-day CMC activities across multiple disciplines and with external partners.
• Manage interactions with CMOs/CDMOs, testing labs and vendors.
• Monitor progress, identify risks, mitigate issues and escalate when needed.
• Provide clear project status updates to teams and governance forums.
• Coordinate preparation of CMC documentation for regulatory submissions (INDs/CTAs).
• Follow up on quality activities, deviations, investigations and CAPAs affecting execution.
• Support project budgeting, forecasting and governance.
• Ensure compliance with Genmab Quality Management System and regulatory requirements.
• Identify opportunities for continuous improvement in processes and tools.

Skills

Project management

Cross-functional leadership

Biologics knowledge

CMOs/CDMOs coordination

Regulatory CMC submissions

English fluency

Education

Master's degree in Life Sciences/Pharmaceuticals

PhD or PM certification (advantage)

Job description

At Genmab, we are dedicated to building extraordinary® 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 valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

Genmab is looking for a Senior Operational Project Manager to join the Early-Stage CMC Project Management Department in Copenhagen. Technical Operations is responsible for the development and manufacture of Genmab's antibody therapeutics supporting preclinical, clinical, and commercial programs. As part of Technical Operations, the Early-Stage CMC Project Management department drives CMC development programs from Discovery through Clinical Proof of Concept (Phase I/II), working closely with cross-functional experts and external partners. As a Senior Operational CMC Project Manager, you will play a central role in translating CMC strategy into operational execution for development programs. You will be responsible for planning, coordinating, and driving day-to-day CMC activities while ensuring alignment across internal functions, external manufacturing partners, and project governance.

You will collaborate with specialists across Process Development, Analytical Development, Manufacturing, Product Characterization, Pharmaceutical Development, Regulatory Affairs, Quality, Supply Chain, and other Technical Operations functions to successfully advance Genmab's pipeline.

You will become part of a highly collaborative team of experienced CMC Project Managers within Early-Stage CMC Project Management and report to the Team Lead, Early-Stage CMC Project Management.

Responsibilities

• Drive the operational execution of integrated CMC development plans from Discovery through IND/CTA and early clinical development (Phase I/II).
• Develop, maintain, and execute integrated CMC project plans, including timelines, milestones, budgets, risks, deliverables, and resource planning.
• Coordinate day-to-day CMC activities across multiple technical disciplines and ensure effective collaboration between internal stakeholders and external partners.
• Manage operational interactions with Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), testing laboratories, and other external vendors.
• Monitor project progress, identify risks and issues proactively, facilitate mitigation plans, and ensure timely escalation when appropriate.
• Facilitate robust cross-functional communication and provide clear project status updates to project teams and governance forums.
• Coordinate preparation and review of CMC documentation supporting global regulatory submissions, including INDs, CTAs, and other health authority interactions.
• Coordinate and follow up on quality-related activities, including deviations, investigations, changes, CAPAs, and other quality events affecting project execution.
• Support project budget management, forecasting, governance activities, and overall project execution.
• Ensure project activities are conducted in compliance with Genmab's Quality Management System and applicable regulatory requirements.
• Contribute to continuous improvement by identifying opportunities to strengthen project management processes, tools, and ways of working within Early-Stage CMC Project Management.

Requirements

To succeed in this role, you bring a strong combination of scientific insight, project management expertise, and the ability to lead complex cross-functional collaborations.

You have:

• A Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, or another relevant scientific discipline. A PhD or project management certification is considered an advantage.
• Approximately 8–10 years or more of relevant experience within CMC, biologics development, Technical Operations, or pharmaceutical development in the biotechnology or pharmaceutical industry.
• Demonstrated experience leading complex CMC development activities supporting biologics from early development through IND/CTA and Phase I/II clinical development.
• Strong project management experience, including planning, scheduling, budgeting, risk management, stakeholder management, and governance.
• Solid understanding of biologics process development, analytical development, GMP manufacturing, and CMC regulatory requirements.
• Experience working successfully with external manufacturing partners (CMOs/CDMOs) and outsourced development activities.
• Experience supporting regulatory CMC submissions and coordinating cross-functional deliverables.
• Strong communication, collaboration, and problem-solving skills.
• Fluency in spoken and written English.

The following experience is considered an advantage:

• Development and manufacturing of antibody-drug conjugates (ADCs), or chemical engineering/API technology would be an asset

• Technology transfer between manufacturing sites or external partners.
• Experience working in an international matrix organization.
• Experience contributing to continuous improvement initiatives and implementation of project management tools or processes.

We are looking for someone who:

• Is an excellent collaborator and builds trusted relationships across functions and with external partners.
• Thrives in a dynamic environment while managing multiple priorities simultaneously.
• Takes ownership, demonstrates accountability, and proactively drives activities to completion.
• Has a structured, analytical, and solution-oriented approach to complex challenges.
• Communicates effectively with stakeholders at all organizational levels.
• Demonstrates sound judgment and maintains a strong quality mindset.
• Is curious, open-minded, and continuously seeks opportunities to improve processes and ways of working.
• Is motivated by delivering high-quality results that contribute to the success of Genmab and, ultimately, better outcomes for patients.

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

DKK644.640,00---966.960,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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