Director, Head of CMC Analytical and Characterization, Manufacturing Science and Technology

At Genmab we are dedicated to building extranotordinary 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

We are seeking a Director CMC Analytical and Characterisation to join our Manufacturing Science and Technology (MSAT) organization within CMC Development and Manufacturing/Technical Operations. This role will support Genmabs growing early to late-stage and commercial biologics (antibody based) pipeline.

The Director will lead a highly specialized team of analytical and protein characterization subject matter experts (SMEs). The group partners closely across CMC Development and Manufacturing Quality CMC Regulatory Product Development QC lab as well external Contract Manufacturing Organizations (CMOs). The main purpose of the team is to ensure robust analytical and characterization packages that support all stages of development regulatory submissions (IND/CTA BLA/MAA) and lifecycle management.

As a member of the MSAT leadership team the Director position will help shaping the analytical and characteriszation strategy across the portfolio and contribute to the overall technical direction of MSAT during a period of significant growth. The position will report into Vice President Manufacturing Science and Technology. MSAT current employs about 40 people covering CMC Analytical and Characterisation CMC Pharmaceutical Development CMC Process Development CMCStability and CMC Writing. About 12 Specialist are currently working within CMC Analytical and Characterization. Significant growth is expected in MSAT during 2026. The successful candidate will have a unique opportunity to set direction for MSAT and the CMC Analytical and Characterization department.

Responsibilities

Responsibilities include but are not limited to:

Leadership & Organization

• Lead and develop the CMC Analytical and Characterisation team including resource planning hiring performance management and career development.

• Foster a high-performing collaborative SME organization supporting multiple programs as well as internal and external stakeholders/partners.

• Contribute to MSAT and Technical Operations strategic planning and execution.

Analytical & Characterization Strategy

• Define and oversee analytical method development qualification validation and lifecycle management strategies.

• Ensure scientifically sound and regulatory-aligned characterization packages for Genmab biologic pipeline as e.g. bispecific antibodies and antibody drug conjugates.

• Provide technical oversight of comparability strategies supporting phase transitions process changes and site transfers.

• Act as an internal expert on analytical and characterization expectations from early to late-stage development and commercialization.

Cross-Functional & External Collaboration

• Partner closely with Genmabs Product Development in Utrecht where non-GMP analytical development testing and characterisation is performed.

• Provide analytical leadership for technology transfer and validation activities from early- to late-stage development and into commercial manufacturing.

• Support CMO oversight related to analytical testing method implementation troubleshooting and method validation.

• Ensure effective communication across MSAT Technical Operations Quality CMC Regulatory and external stakeholders.

Regulatory & Quality Support

• Support preparation and review of CMC analytical and characterisation sections of global regulatory submissions.

• Support interaction with regulatory authorities based on your prior experience of e.g RFIs or PAIs.

• Ensure that your team supports ongoing quality events during GMP manufacture and testing as e.g. manufacturing/method deviations OOS or potential recalls.

• Contribute to the maintenance and continuous improvement of Technical Operations quality systems.

Operational Support

• Provide hands-on scientific and technical as well as quality systems support to team members as needed.

• Manage multiple priorities across a diverse project portfolio in a fast-paced development environment.

• Estimated travel: approximately 1015 days per year.

Requirements

Education & Experience

• Masters degree or higher in a relevant scientific discipline (e.g. analytical chemistry biochemistry pharmacy biotechnology or related field).

• Minimum of 10-15 years of industry experience within CMC for biopharmaceutical development with significant exposure to late-stage programs.

• Strong scientific expertise in analytical methods and/or protein characterization for biologics preferably from antibodies or antibody drug conjugates.

• Demonstrated experience contributing to regulatory submissions and engaging with global health authorities.

• Prior people management experience at least 5-8 years.

Core Competencies

• Proven ability to lead and develop technical experts in a matrix-based project-driven environment.

• Strong strategic thinking combined with hands-on scientific credibility.

• Ability to work effectively under pressure and manage complex parallel deliverables.

• Collaborative mindset with strong communication skills across internal and external stakeholders.

• Results-driven organized and capable of prioritizing work to meet aggressive timelines.

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!

Locations

Genmab 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 youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

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 Genmabs 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 and follow us on LinkedIn and X.

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