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 SME’s for e.g. 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.

Key Responsibilities Include

• 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

Requirements

• 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, preferable from late stage development
• You have a thorough understanding of the detailed requirements for development of biological drug products and is 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

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.