Senior CMC Specialist, Analytical

Senior CMC Specialist, Analytical

Genmab

Utrecht, Netherlands

The Role

As the Senior CMC Specialist, Analytical, you will act as the analytical subject matter expert (SME) within the CMC Peto team, supporting late-phase development activities, lifecycle management, and preparation of CMC packages for regulatory filings. This is a highly technical and hands-on analytical role with a strong focus on GMP analytical activities, assay validation, and analytical lifecycle management. You will work closely with CMOs and cross-functional project teams to support analytical development, validation, characterization, and regulatory readiness across Genmab’s biologics portfolio. The role requires a strong degree of independence within the analytical domain and close collaboration with internal SMEs in upstream, downstream, and characterization functions.

You will join an expanding international team currently consisting of eight colleagues, where collaboration, knowledge sharing, curiosity, and scientific excellence are highly valued. The position is based in Utrecht and reports to the Executive Director Product Development, CMC.

Responsibilities

• Lead and oversee analytical method strategies, including method development, qualification, validation, transfer, and lifecycle management
• Act as the analytical SME for CMC development activities, providing scientific and technical oversight of analytical activities performed at Genmab’s partnered CMOs
• Drive analytical validation activities and ensure regulatory compliance for analytical validation strategies and documentation
• Manage the lifecycle of assigned analytical development and quality control methods supporting clinical development programs
• Execute continuous GMP analytical improvement initiatives, including maintaining validated states, method improvements, and compliance-related activities
• Support analytical activities related to phase transitions, process changes, technology transfers, and site transfers
• Establish fit-for-purpose and regulatory-aligned characterization packages across the biologics pipeline
• Collaborate with Product Development teams in Utrecht on non-GMP analytical activities supporting characterization and testing strategies
• Troubleshoot analytical and laboratory-related issues, lead investigations and deviations, and implement both short- and long-term resolutions
• Author, review, and maintain technical documentation, regulatory filing documentation, and Standard Operating Procedures (SOPs), including contributions to BLA/MAA submissions
• Ensure compliance with Genmab’s quality systems and applicable GMP requirements
• Work cross-functionally with CMC Project Managers and other SMEs to strengthen analytical strategies and support late-stage development activities

Requirements

• MSc or PhD degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or another relevant scientific discipline
• Minimum 5 years of experience within Analytical CMC, preferably within late-stage biologics development
• Strong expertise in analytical method validation, assay lifecycle management, and GMP analytical activities
• Solid understanding of process characterization, risk assessments, and late-stage validation activities
• Experience with analytical activities supporting regulatory filings and market authorizations
• Proven ability to independently manage analytical topics and act as a technical SME within cross-functional teams
• Experience working with CMOs and external partners in a regulated environment
• Strong problem-solving and troubleshooting skills within analytical and laboratory settings
• Proactive and solution-oriented mindset with the ability to work effectively in a fast-paced environment with ambitious timelines
• Well-organized with strong planning and execution skills
• Excellent communication and stakeholder management skills
• Fluent in English, both written and verbal
• Collaborative, curious, and flexible team player with a strong sense of ownership and accountability

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!