(Senior) CMC Analytical Specialist

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

The Genmab CMC Late Stage Manufacturing Development (LSMD) Team is looking for a (Senior) Analytical CMC Specialist. 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) Analytical 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). You will work across project teams to support the CMC Project Managers and work closely with other specialists for e.g. upstream processing, downstream processing, and characterization as well as with relevant specialists within partner programs and areas.

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

Key Responsibilities Include

• Responsible for the LSMD analytical strategy on ongoing projects.

• Day to day oversight of analytical activities performed at partnered CMOs according to the latest industry standards and regulatory guidance.

• Prepare/review technical documents including development/validation/transfer protocols and reports.

• Author and review of CMC regulatory analytical submissions documents.

• Work closely with characterization SME’s to develop late stage development analytical/characterization strategies.

• Support defining/refining required processes for analytical/characterization activities.

• 5-10 days of travel per year are expected.

Requirements

• Master’s degree in natural science, pharmacy, or similar.

• At least 5 years of documented professional experience with analytical methods for GMP manufacturing, preferable from late stage development.

• Thorough understanding of the detailed requirements for analytical validation and be up to date with current trends.

• You preferable have active and recent experience within analytical development and validation of methods for biologics/monoclonal antibodies from a phase II/III program.

• Experience with chromatographic and pharmacopeia methods for biologics is preferred, along with proficiency in other analytical techniques.

• Familiarity with establishing and maintaining reference standards is also highly desirable.

• It is also 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.

This role is based in Copenhagen 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. 

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