CMC Senior Analytical & Characterization Specialist

. We are especially interested in candidates with experience spanning both

, including

. @@HD@@ You will join a highly specialized CMC Analytical and Characterization team@@/HD@@ and will be working as a

in a collaborative environment in a matrix organization focused on enabling robust analytical strategies for increasingly complex therapeutic platforms. You will partner closely with: • CMC Project Managers. • MSAT colleagues across CMC Process Development, CMC Stability, CMC Pharmaceutical Development, and CMC Writing. • Cross-functional stakeholders in Quality, CMC Regulatory, Product Development (our non-GMP CMC development lab in Utrecht, NL), and Genmab QC (Ballerup, DK). • External partners, including Contract Manufacturing Organizations in a network across the globe (CMOs). You will serve as the analytical and characterization SME responsible for defining analytical direction and providing technical leadership across development, manufacturing and regulatory activities. @@HD@@ Responsibilities@@/HD@@ @@HD@@ • Lead and manage analytical method strategies,@@/HD@@ including development, qualification, validation, transfer, and lifecycle management for e.g. biologics, conjugated therapeutics. • Provide

of analytical activities at CMOs and external analytical laboratories. •

for activities related to phase transitions, process changes, and site transfers. • Drive implementation of analytical and characterization strategies across projects involving

. •

technical reports, specifications, comparability assessments, SOPs, and regulatory documentation, including contributions to BLA/MAA submissions. • Establish fit-for-purpose, regulatory-aligned characterization packages across the biologics pipeline, with emphasis on

, including drug-to-antibody ratio (DAR), payload-related impurities, and conjugation heterogeneity. • Act as a trusted subject matter expert

from early-stage development through commercialization. • Support implementation and

of internal processes related to analytical method validation, method transfers, and method performance reviews. •

with early development areas such as Product Development on non-GMP analytical activities supporting characterization and testing strategies and Late stage or Life cycle management teams enabling seamless operations. • Work cross-functionally to strengthen

, platform approaches, and technical capabilities for emerging therapeutic modalities.

, including knowledge of: • Small molecule payloads • Linker chemistry • Conjugation strategies • Impurity characterization • Experience working across both

is highly preferred. • Familiarity with analytical techniques relevant to ADCs and complex biologics, such as CEX, CE-SDS, SEC, icIEF, peptide mapping, and related characterization methods. • Experience with regulatory documentation and submissions (e.g., BLA, MAA), including analytical and characterization sections supporting late-stage development and commercialization. • Excellent communication skills in English, with the ability to engage effectively across functions, cultures, and external partners. @@HD@@Moreover, you are someone that is: • S@@/HD@@

and excited by the challenges of developing next-generation therapeutics combining biologics and small molecule technologies. • You thrive in

and enjoy solving multidisciplinary analytical challenges. • You bring

to all that you do. • You are a collaborative partner who enjoys working across analytical, process, pharmaceutical, and regulatory functions. • You are comfortable navigating ambiguity and helping shape analytical strategies for emerging modalities. • You are motivated by the opportunity to make a direct impact on innovative therapies for patients with serious diseases. If you find this to be a match for you - don't hesitate to apply to this position in Genmab. The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK--- The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to: • Pension • Health insurance and wellness benefits • Paid time off • Employee support programs Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. @@HD@@ About Genmab@@/HD@@ Genmab 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) .