Project Manager CMC

The Role

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 produ...