Senior CMC Specialist, Drug Product

<p><span>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.</span></p><p></p><p><b>The Role &amp; Department</b></p><p>Are you interested in joining our highly talented Late-Stage Manufacturing Development (LSMD) team in CMC operations in Copenhagen? You’ll work closely with our commercial supply chain and manufacturing stakeholders. With Genmab’s expansive growth, we are dedicated to maintaining and improving our commercial products, and we need your life-cycle management experience to join us on this amazing journey!</p><p></p><p>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 worldwide, we are expanding our life-cycle management capabilities for late-stage and commercial manufacturing within the LSMD team.</p><p></p><p>This position reports to Associate Director, Team Lead, Pharmaceutical Development, Late-Stage Manufacturing Development, based in Copenhagen and is hybrid.</p><p></p><p><b>Responsibilities</b></p><p>As the Senior Specialist, Drug Product, Life Cycle Management, you will be responsible for providing scientific support for drug product activities related to Genmab’s commercial products. This includes scaling up and implementing process changes as part of our commitment to continuous improvement. You will collaborate closely with other SMEs in areas such as late-stage drug product development, as well as with colleagues in the commercial supply chain, regulatory affairs, and QA.</p><ul><li><p>Serve as the Drug Product Subject Matter Expert (SME) for Genmab commercial products.</p></li><li><p>Providing day-to-day support for commercial drug product manufacturing activities conducted at Genmab’s partnered CMOs or partner companies.</p></li><li><p>Evaluating change controls and deviations related to drug products.</p></li><li><p>Collaborating with other departments to develop commercial drug product strategies and refine necessary processes.</p></li><li><p>Leading drug product development activities for Genmab commercial products</p></li><li><p>Writing / reviewing of regulatory documentation for Genmab commercial products</p></li></ul><p></p><p><b>Requirements</b></p><ul><li><p>Master's degree in science, pharmacy, or a related technical area. </p></li><li><p>8+ years of experience in CMC or related areas in pharmaceutical, biotechnology, and/or medical device industry, preferably within life-cycle management of products or commercial manufacturing.</p></li><li><p>Experience with late-stage development and commercialization of biologic drug products.</p></li><li><p>Experience with regulatory documentation, including regulatory commitments, and quality documentation according to Good Manufacturing Practice.</p></li><li><p>Ability to write and review documentation for regulatory market authorizations (e.g., BLA, MAA) and clinical trial applications.</p></li><li><p>Excellent communication skills in English (both written and oral) and the ability to work in multicultural teams </p></li><li><p>Ensure compliance with applicable regulatory guidelines and industry standards.</p></li><li><p>Travel can be expected.</p></li></ul><p></p><p><b>About You</b></p><ul><li>You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment</li><li>You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving</li><li>You are a generous collaborator who can work in teams with diverse backgrounds</li><li>You are determined to do and be your best and take pride in enabling the best work of others on the team</li><li>You are not afraid to grapple with the unknown and be innovative</li><li>You have experience working in a fast-growing, dynamic company (or a strong desire to)</li><li>You work hard and are not afraid to have a little fun while you do so</li></ul><p></p><p><b>Locations</b></p><p>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.</p><p></p><p><b>About Genmab</b></p><p>Genmab is an international biotechnology company