Senior Specialist, CMC Analytical

Senior Specialist, CMC Analytical

Genmab

Copenhagen, Denmark

The Role

At Genmab, we’re committed to transforming the lives of people with cancer through innovative antibody therapeutics. As part of our continued growth, we are looking for a Senior CMC Analytical Specialist to join our Manufacturing Science & Technology (MSAT) organization within CMC Development & Manufacturing/Technical Operations.

In this role, you will contribute to advancing our diverse biologics pipeline - from early development through commercialization - with a particular focus on antibody-based modalities, including bispecific antibodies and Antibody-Drug Conjugates (ADCs).

You will join a highly specialized CMC Analytical and Protein Characterization team, working as a Subject Matter Expert in a collaborative, matrix environment.

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).

Your work will be central to ensuring robust analytical and characterization strategies, enabling successful development, regulatory submissions (BLA/MAA), and lifecycle management.

At Genmab, 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.

Responsibilities

• Lead and oversee analytical method strategies, including development, qualification, validation, transfer, and lifecycle management.
• Establish fit-for-purpose, regulatory-aligned characterization packages across the biologics pipeline.
• Provide scientific and technical oversight of analytical activities at CMOs.
• Collaborate with Product Development (Utrecht) on non-GMP analytical activities supporting characterization and testing strategies.
• Support analytical activities related to phase transitions, process changes, and site transfers.
• Act as a trusted subject matter expert, guiding analytical and characterization approaches from early-stage development through commercialization.
• Drive the implementation of analytical and characterisation strategies across projects.
• Author and review technical and regulatory documentation, including contributions to BLA/MAA submissions.
• Work cross-functionally to strengthen late-stage analytical strategies and processes.

Requirements

• Master’s degree in Science, Pharmacy, or a related field (PhD or additional qualifications are an advantage).
• 8–10+ years of experience within CMC or a related area in the pharmaceutical or biotechnology industry.
• Strong expertise in analytical validation and characterization, including small molecule, and biologics, preferably from Antibody Drug Conjugate projects.
• Experience with regulatory documentation and submissions (e.g., BLA, MAA).
• Excellent communication skills in English, with the ability to engage effectively across functions and cultures.

About You

• You are genuinely passionate about our purpose.
• You bring precision and excellence to all that you do.
• You believe in our rooted-in-science approach to problem-solving.
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds.
• You take pride in enabling the best work of others on the team.
• You can 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!