CMC Life-cycle and Commercial Project Manager

At Genmab, we’re 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.

The Role & Department

Are you ready to join our dynamic Late-Stage Manufacturing Development (LSMD) team in Copenhagen? At Genmab, we’re experiencing rapid growth and are committed to enhancing our late-stage and commercial products. We need your expertise in late-stage and life-cycle management to help us on this exciting journey!

In this role, you’ll work closely with our commercial supply chain, subject matter experts, regulatory affairs, and QA teams. The LSMD team is responsible for the late-stage development of Genmab’s portfolio projects and providing scientific support to the commercial supply chain. With a growing portfolio of commercial products worldwide, we’re expanding our life-cycle management capabilities within the LSMD team.

As the CMC Life-cycle and Commercial Project Manager, you’ll oversee Genmab’s commercial programs, coordinating and planning activities with our partnered CMOs. You’ll collaborate closely with colleagues in LSMD, the commercial supply chain, regulatory affairs, and QA to ensure seamless operations.

Join our talented team of 30 professionals in LSMD and report directly to the LSMD Project Management Team lead. This role is located in Copenhagen, Denmark. We are reviewing applications on a rolling basis as they come in.

Responsibilities

• Provide day-to-day support for commercial manufacturing activities at Genmab’s partnered CMOs or partner companies.

• Manage commercial commitments to various health authorities.

• Support and follow up on CMO and internal quality events, such as changes or deviations.

• Maintain the quality system of CMC Operations.

• Coordinate and manage projects with external partners, as Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture.

Requirements

• Master’s degree in relevant natural sciences.

• 5+ years of experience in biopharmaceutical, preferably with therapeutic monoclonal antibody or protein development.

• 5+ years of experience in CMC project management.

• Proven track record in biological process development/biopharmaceutical manufacturing.

• Experience with the CMC technical sections of regulatory submissions and interacting with global regulatory authorities.

• Excellent communication skills in English and the ability to work in multicultural teams.

• Ability to manage multiple tasks, prioritize work, and achieve project and team goals.

• 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 passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. 

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. 

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 Job Applicant Privacy Notice (genmab.com).