CMC Specialist, Drug Product

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 Genmab CMC Late Stage Manufacturing Development (LSMD) Team is looking for a (Senior) CMC Specialist, Drug Product for our growing project portfolio. The LSMD Team is responsible for the late-stage development activities of Genmab's portfolio projects and scientific support to the commercial supply chain.

As the (Senior) Drug Product Specialist, you will be part of a highly dedicated and specialized CMC team leading the late stage development activities of Genmab's proprietary antibody pipeline programs towards marketing approval (BLA/MAA).

The Drug Product Specialist will work in project teams to support the CMC Project Managers and work closely with other SMEs for late-stage drug product development, as well as our clinical and commercial supply chain colleagues, regulatory affairs and QA. Furthermore, you will work closely with partnered CMOs.

Anticipated travel is expected 5-10 days per year.

This position reports to Associate Director, Team Lead, Pharmaceutical Development, Late Stage Manufacturing Development, based in Copenhagen.

• Responsible for / support to drug product process characterization and process validation activities performed at CMOs according to latest industry standards and regulatory guidance.
• Prepare/review technical documents including development/validation/technical transfer protocols and reports.
• Authoring and review of CMC regulatory submissions documents related to Drug Product.
• Work closely with Drug Product CMC Project Manager to develop late stage development strategies for Drug Product including definition of the needed activities for regulatory MAA/BLA filing.
• Support the establishment of relevant LSMD Department / Pharmaceutical Development team processes.
• Support Genmab oversight of late stage drug product CMO activities.

• It is expected that you have a master's degree in natural science, pharmacy, or similar.
• You have at least 8 years of documented professional experience with drug product development and/or GMP manufacturing, preferably from late stage development.
• You have a thorough understanding of the detailed requirements for development of biological drug products and are up to date with current trends.
• It is preferred that you have experience in preparing and reviewing relevant filing documentation for regulatory market authorizations (e.g. BLA, MAA, J-NDA).
• Excellent communication skills in English written and oral.

• 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

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.

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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