CMC Analytical SME

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
Do you want to join our highly talented Late-Stage Manufacturing Development (LSMD) in CMC operation in Copenhagen, and work in close collaboration with our commercial supply chain and manufacturing stakeholder? With Genmab’s expansive growth, we work with great energy to maintain and improve our commercial products, and we need you to join in our amazing journey and contribute with your life-cycle management experience!

The LSMD is responsible for the late-stage development activities of Genmab’s portfolio projects and scientific support to the commercial supply chain. With a growing portfolio of commercial products available across the world, we are expanding the life-cycle management capabilities for late-stage and commercial manufacturing within the LSMD team.

You will work closely with other SME’s for e.g. analytical validation and upstream/downstream processing, as well as our commercial supply chain colleagues, regulatory affairs and QA.

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

Key Responsibilities Include

• Serve as the analytical Subject Matter Expert (SME) for Genmab commercial products.
• Lead analytical method development, product characterization, and product specification activities.
• Day-to-day support to commercial manufacturing activities performed at Genmab partnered CMOs or our partner companies.
• Evaluating change controls and deviations related to analytics.
• Collaborate with other areas to develop commercial analytical/ characterization strategies and refine required processes.

Requirements

• A Master's degree in science, pharmacy, or a related technical area.
• Experience within the pharmaceutical or biotechnology industry, preferable within life-cycle management of product or commercial manufacturing.
• Hands-on experience with analytical and/or characterization methods for biologics, preferable from within a regulated environment.
• Ability to review and write documentation for regulatory market authorizations(e.g. BLA, MAA) or amendments thereof.
• Excellent communication skills in English (both written and oral) and the ability to work in multicultural teams.
• Goal-oriented with a focus on achieving outcomes important to the team and organization.
• Proactive, taking initiative and responsibility in a fast-paced environment.
• Strong ability to work under pressure with tight timelines.
• Team player capable of collaborating with a diverse group of internal and external stakeholders.

This role is based in Copenhagen, Denmark and is hybrid.

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).

Location: Copenhagen - Carl Jacobsens Vej 30