Senior CMC Analytical specialist

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.Does this inspire you and feel like a fit? Then we would love to have you join us!The Role & DepartmentDo you want to join our highly talented team of late-stage product characterization and analytics specialists in Copenhagen? With Genmab’s continuous maturation, we work with great energy to prepare the CMC package for regulatory filings, and we need you to join in our amazing journey and contribute with your experience on analytical methods for small molecules and peptides!Late Stage Manufacturing Development is responsible for the late-stage development activities of Genmab’s portfolio projects and preparation of the CMC package for regulatory filings. As the (senior) analytical specialist, will work across project teams to support the project managers and work closely with other specialists e.g. upstream processing, downstream processing, and characterization as well as external stakeholders.Key Responsibilities IncludeDevelopment and implementation of the LSMD analytical and characterization strategy for ongoing projectsDay-to-day oversight of characterization activities performed at Genmab partnered CMOs and internal Genmab laboratoriesPrepare and review technical documents and author regulatory submission documentsCollaborate with other areas to develop late-stage analytical/characterization strategies and refine required processesRequirementsMaster's degree in science, pharmacy, or a related technical area; advanced degree or certification preferredMinimum of 8 years of experience in CMC or a related area within the pharmaceutical or biotechnology industryYou have a thorough understanding of the detailed requirements for analytical validation and requirements for small-molecule / peptide analytics.Ability to author and review documentation for regulatory market authorizations (e.g., BLA, MAA)Excellent communication skills in English (both written and oral) and the ability to work in multicultural teamsProfessional QualitiesGoal-oriented with a focus on achieving outcomes important to the team and organizationProactive, taking initiative and responsibility in a fast-paced environmentStrong ability to work under pressure with tight timelinesTeam player capable of collaborating with a diverse group of internal and external stakeholdersThis role is located in Copenhagen, Denmark and is hybrid.About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can grapple with the unknown and be innovativeYou 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!LocationsGenmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.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).