Project Manager CMC

Project Manager CMC

Genmab

Copenhagen, Denmark

The role provides CMC project management and technical support for late-stage drug product (DP) development projects. The position supports pharmaceutical development, process characterization, validation, regulatory submissions, and interactions with CMOs, partners, and regulatory authorities, ensuring all activities are executed in compliance with Genmab’s quality systems and regulatory requirements.

Key Responsibilities

• Provide CMC project management support for late-stage drug product development projects, including pharmaceutical development activities for liquid and lyophilized drug products
• Act as the responsible project manager for assigned drug product–related activities
• Support drug product process characterization and validation activities in accordance with regulatory requirements
• Support the development and execution of drug product activities required for regulatory filings, in close collaboration with the Genmab late-stage organization
• Review and approve technical and quality documents from contract manufacturing organizations (CMOs)
• Assist with technical transfer activities between CMOs and external partners
• Support the authoring and review of CMC sections of regulatory submissions, including IND/IMPD and BLA/MAA
• Support Regulatory Affairs in communications and interactions with health authorities
• Drive interactions with CMOs, including follow-up on timelines and technical and quality topics
• Support internal and external inspections, including inspections at CMOs
• Ensure all CMC activities are performed in compliance with Genmab’s quality systems and applicable regulations

Requirements

• Minimum of a Master’s degree in a scientific or technical discipline, preferably Pharmaceutical Sciences, Chemical Engineering, or a related field
• An advanced degree and/or relevant professional certification within the area of Drug Product Development is preferred
• Minimum of 5 years of experience within the pharmaceutical, biotechnology, and/or medical device industry, with demonstrated experience in the execution of drug product (DP) processes
• Proven track record of project management experience, including planning, execution, follow-up, and coordination of cross-functional teams of specialists
• The position has a strong focus on stakeholder management and requires strong communication skills and the ability to collaborate effectively across functions and cultures
• Experience working in a global organization and with external partners, including CMOs, could be considered an advantage

Key Competencies

• Strong understanding of late-stage CMC drug product process development, as well as the manufacture of lyophilized and liquid products
• Strong team player who thrives and prioritizes working in a team while maintaining a strong stakeholder network
• Solid knowledge of regulatory requirements and quality systems
• Structured, proactive, and detail-oriented approach to project execution
• Ability to manage multiple stakeholders and priorities in a fast-paced environment

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