Senior CMC Project Manager, Late-Stage Manufacturing
1 week ago
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 Genmab is looking for a Senior CMC Project Manager to join our Late-Stage Manufacturing Development (LSMD) Team, which is responsible for process characterization, process validation activities, and submitting market authorization applications. As a Senior CMC Project Manager, you will support the CMC Lead of one of Genmab's late stage development programs and you will be responsible for the coordination and planning of activities performed at our partnered CMO's. Join our dedicated team of 30 professionals at LSMD and report directly to the LSMD Project Management Team Lead, in Copenhagen, Denmark. Responsibilities Manage CMC activities at CMOs related to mAbs, small molecules and ADC manufacturing. Internal alignment in the CMC Management Team governing a CMC program within Genmab. Support authoring and reviewing of regulatory CMC submissions (BLA, MAA, JNDA). Support and follow up on CMO and internal quality events as e.g. changes or deviations. Support the maintenance of CMC Operations' quality system. Secure clinical supply. Requirements Master's degree in relevant natural sciences. 8+ years of experience in biopharmaceutical, preferably with therapeutic monoclonal antibody or ADCs. 8+ years of experience in CMC project management. Proven track record and technical skills in biological process development/biopharmaceutical manufacturing. As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture, experience in running projects with external partners is preferred. 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 work successfully under pressure in a fast-paced environment and with tight timelines. 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) .
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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...
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