Senior Project Manager, CMC Life Cycle Management

Genmab A/S; København; On-site; DKK 80,000 - 110,000; Full time

Job summary

Genmab A/S is seeking a Senior CMC Project Manager in Copenhagen to manage the CMC lifecycle activities of its commercial products. The role requires collaboration with various internal teams to ensure seamless project execution and regulatory compliance.

The ideal candidate should hold an advanced degree and have at least 7 years of experience in the biopharmaceutical industry. Strong project management and communication skills are essential for this position, as well as a passion for contributing to the company's growth and success.

Qualifications

• Minimum of 7 years of experience in the biopharmaceutical industry, preferably with monoclonal antibodies.
• Proven track record in CMC project management.
• Experience with regulatory submissions and cGMP requirements.

Responsibilities

• Provide day‑to‑day project management support for commercial manufacturing activities.
• Collaborate with Regulatory Affairs and Commercial QA for cross-functional planning.
• Manage CMC commitments and support Post‑Approval Change Management.

Skills

Project management

Stakeholder management

Communication

Collaboration

Organizational skills

Education

Advanced degree (MSc or PhD) in Pharmacy, Chemistry, Biotech, or Engineering

Job description

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.

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

• Provide day‑to‑day project management support for commercial manufacturing activities at Genmab’s partnered CMOs, including change controls, deviations and release.
• Collaborate 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, including 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.
• 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.

About You

• You are genuinely passionate about our purpose.
• You bring precision and excellence to all that you do.
• You believe in our rooted‑in‑science approach to problem‑solving.
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds.
• You take pride in enabling the best work of others on the team.
• You can grapple with the unknown and be innovative.
• You have experience working in a fast‑growing, dynamic company (or a strong desire to).
• You work hard and are not afraid to have a little fun while you do so.

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work‑life balance. Our offices are crafted as open, community‑based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.