Senior Project Manager, CMC Life Cycle Management

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 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!

At Genmab, we are 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 science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

About the Role

Genmab is seeking a Senior CMC Project Manager to join the CMC Life Cycle Management (LCM) Team and support our growing portfolio of commercial products globally.

The LCM team is responsible for managing the CMC lifecycle activities of Genmab's commercial products, ensuring supply continuity, regulatory compliance, and successful execution of post-approval activities throughout the product lifecycle. In this role, you'll work closely with colleagues across Commercial Supply Chain, MSAT, Regulatory CMC, Commercial QA and External Manufacturing to ensure seamless execution of lifecycle management activities.

The CMC Life Cycle Management Team is part of CMC Project & Portfolio Management (PPM) which also includes the Early-Stage Development, Late-stage Development and External Manufacturing teams. CMC Project & Portfolio Management resides within CMC Development and Manufacturing, based in Denmark.

This role offers a unique opportunity to contribute to the continued growth of Genmab's commercial portfolio while working in a highly collaborative and cross-functional environment at the interface of development, manufacturing, supply, and regulatory affairs.

Key Responsibilities

As the CMC Project Manager, you'll oversee Genmab's commercial programs by:

• Provide day-to-day project management support for commercial manufacturing activities at Genmab's partnered CMOs, incl. change controls, deviations and release
• Collaborating with Regulatory Affairs, Commercial QA, CMC Late-Stage Development, MSAT and Commercial Supply Chain to drive cross-functional planning and execution
• Manage CMC commitments and support Post-Approval Change Management, incl. regulatory submission in collaboration with MSAT, Commercial QA, Regulatory CMC, CMC writing, and PD Development
• Support technical and operational items for product-specific roadmaps, e.g. line extensions, SKU expansion, dosage form modifications, or new market introductions, etc.
• Support initiatives to optimize yield, reduce cost of goods, and enhance robustness of manufacturing and testing processes
• Support the further development of LCM processes and ways-of -working

Requirements

• Advanced degree (MSc or PhD) in Pharmacy, Chemistry, Biotech, Engineering, or a related scientific discipline
• Minimum of 7 years of experience in biopharmaceutical industry, preferably with therapeutic monoclonal antibody and/or protein development
• Proven track record in CMC project management across development and commercialization activities
• Prior experience with commercial product lifecycle management and oversight of Contract Manufacturing Organizations (CMOs) is considered an advantage.
• Broad understanding of global cGMP requirements and regulatory expectations across major markets
• Experience supporting the CMC technical sections of regulatory submissions and interacting with global regulatory authorities
• Excellent communication and stakeholder management skills, with fluency in English
• Demonstrated ability to work effectively in cross-functional and multicultural environments
• Strong organizational skills with the ability to manage multiple priorities, balance competing demands, and deliver against project timelines
• Team player with the ability to collaborate with diverse stakeholders.
• Result- and goal-oriented, committed to contributing to Genmab's success

The proposed gross annual 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 to 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 compensation and benefits 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.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website

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