CMC Senior Analytical & Characterization 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!

As part of our continued growth, we are looking for a Senior CMC Analytical and Characterization Specialist to join our Manufacturing Science & Technology (MSAT) organization within CMC Development & Manufacturing / Technical Operations.

Collaboration, scientific excellence, and accountability are at the heart of everything we do - and your contributions will directly support our mission to bring impactful therapies to patients.

The Role

In this role, you will contribute to advancing our diverse biologics pipeline with a particular focus on complex antibody-based modalities, including bispecific antibodies, Antibody-Drug Conjugates (ADCs), and next-generation conjugated therapeutics.

We are especially interested in candidates with experience spanning both biologics and small molecule analytical sciences, including payloads, linker technologies, conjugation chemistry, and ADC characterization strategies.

You will join a highly specialized CMC Analytical and Characterization team and will be working as a Subject Matter Expert 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).

• Lead and manage analytical method strategies, including development, qualification, validation, transfer, and lifecycle management for e.g. biologics, conjugated therapeutics.
• Provide scientific and technical oversight of analytical activities at CMOs and external analytical laboratories.
• Act as scientific and technical analytical subject matter expert for activities related to phase transitions, process changes, and site transfers.
• Drive implementation of analytical and characterization strategies across projects involving complex biologics, small molecule payloads, and linker technologies.
• Author and review 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 ADC-specific analytical challenges, including drug-to-antibody ratio (DAR), payload-related impurities, and conjugation heterogeneity.
• Act as a trusted subject matter expert, guiding analytical and characterization approaches from early-stage development through commercialization.
• Support implementation and continuous improvement of internal processes related to analytical method validation, method transfers, and method performance reviews.
• Collaborate 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 late-stage analytical strategies, platform approaches, and technical capabilities for emerging therapeutic modalities.

• Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific field (PhD preferred).
• 8-10+ years of experience within CMC Analytical Development, MSAT, or a related GMP regulated area in the pharmaceutical or biotechnology industry.
• Strong expertise in setting up robust analytical methods at CMOs and external laboratories, validation, and characterization for biologics and/or conjugated therapeutics.
• Hands-on experience with ADC analytical characterization, including knowledge of:
  
  
  • Small molecule payloads
  • Linker chemistry
  • Conjugation strategies
  • Impurity characterization
• Experience working across both large molecule and small molecule analytical disciplines 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.

• Scientifically curious and excited by the challenges of developing next-generation therapeutics combining biologics and small molecule technologies.
• You thrive in complex technical environments and enjoy solving multidisciplinary analytical challenges.
• You bring precision, scientific rigor, and accountability 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.

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs