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

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

Genmab

Copenhagen, Denmark

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 Genmab’s 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, CMC Stability 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 Genmab’s 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 10–15 days per year.

Requirements

Education & Experience

• Master’s 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!